NOVEMBER 2012

WEEK ENDING NOVEMBER 24

Bracco Diagnostics Inc. Issues  Recall of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes 

Bracco Diagnostics Inc. (BDI) is recalling nine (9) lots of Isovue® (iopamidol injection) Pre-Filled Power Injector Syringes (Isovue PFS, to be used in combination with Stellant® CT Injection Systems) due to the presence of visible particles in syringes. 

Isovue PFS is a single use item, administered for diagnostic imaging under medical supervision. The product is packaged in single dose Prefilled Syringe (PFS) presentations of Isovue® - 300 FLS2 and Isovue® - 370 FLS2. The affected Isovue PFS lots include the following:

Isovue® - 370 NDC Description Lot Number Expiry Date
Isovue® - 370 FLS2 0270-1316-66 10 X 75 mL Power Injector Syringes, Stellant 9L40746 12/31/2012
Isovue® - 370 FLS2 0270-1316-67 10 X 100 mL Power Injector Syringes, Stellant 0A43705 01/31/2013
Isovue® - 370 FLS2 0270-1316-67 10 X 100 mL Power Injector Syringes, Stellant 0C57509 03/31/2013
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 9K37791 11/30/2012
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 0C57521 03/31/2013
Isovue® - 370 FLS2 0270-1316-68 10 X 125 mL Power Injector Syringes, Stellant 0E62913 05/31/2013
Isovue® - 300 NDC Description Lot Number Expiry Date
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 9K34572 11/30/2012
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 0A43282 01/31/2013
Isovue® - 300 FLS2 0270-1315-67 10 X 100 mL Power Injector Syringes, Stellant 0C56283 03/31/2013

These products were distributed to wholesalers and distributors nationwide. The dates for distribution of the nine (9) affected lots were from January 21, 2010 through May 9, 2012. BDI is notifying wholesalers, distributors and customers by mail and is arranging for return of all recalled product. Hospitals, Emergency Rooms, Clinics, Physician Offices and other healthcare facilities and providers should not use these lots of Isovue PFS and should immediately quarantine product and contact Stericycle, Bracco’s contractor for handling the recall, at 1-866-201-9133 to arrange for return of the product. Call center hours are Monday through Friday 8am-5pm Eastern Standard Time. 

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures. Catalog #: PT-Module Class II Dako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open. Dako North America Inc.
Devices Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16400 serial numbers: 1001-1141, 1143-1274,1333 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16405 serial numbers: 1001-1466. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16406 serial numbers: 1001-1004,1007-1055,1057-1310, 1648, 1649, 1657, 1822, and 1823. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16409 serial numbers: 1001-1026 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. catalog number: 16410 serial numbers:1001-1034,1036-1061,and 1602-1622. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Special Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection. Multiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40, 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40, 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40, 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40, 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40, 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B PAR FEM EXT V-40, 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40, 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40, 50MM C-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B PAR FEM EXT V-40, 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40, 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER C-KM33-6-603 RX3366D 60MM EXT W/FEMALE V40 TAPER C-KM34-8-902 RX3489C 40MM EXT W/FEMALE V40 TAPER C-KM35-4-501 RX3545B 40MM EXT W/FEMALE V40 TAPER C-KM35-4-502 RX3545C 50MM EXT W/FEMALE V40 TAPER C-KM35-4-503 RX3545D 60MM EXT W/FEMALE V40 TAPER C-KM35-5-501 RX3555B 40MM EXT W/FEMALE V40 TAPER C-KM35-5-502 RX3555C 50MM EXT W/FEMALE V40 TAPER C-KM35-5-503 RX3555D 60MM EXT W/FEMALE V40 TAPER C-KM35-9-001 RX3590B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-101 RX3751B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-102 RX3751C 50MM EXT W/FEMALE V40 TAPER C-KM37-5-103 RX3751D 60MM EXT W/FEMALE V40 TAPER C-KM37-7-100 RX3771A 40MM EXT W/FEMALE V40 TAPER C-KM37-7-101 RX3771B 50MM EXT W/FEMALE V40 TAPER C-KM37-7-102 RX3771C 60MM EXT W/FEMALE V40 TAPER C-KM37-7-801 RX3778B 40MM EXT W/FEMALE V40 TAPER C-KM37-7-803 RX3778D 60MM EXT W/FEMALE V40 TAPER C-KM37-8-401 RX3784B 40MM EXT W/FEMALE V40 TAPER C-KM37-8-402 RX3784C 60MM EXT W/FEMALE V40 TAPER C-KM38-1-301 RX3813B 40MM EXT W/FEMALE V40 TAPER C-KM38-1-302 RX3813C 50MM EXT W/FEMALE V40 TAPER C-KM38-1-303 RX3813D 60MM EXT W/FEMALE V40 TAPER C-KM39-1-101 RX3911B 40MM EXT W/FEMALE V40 TAPER C-KM39-1-102 RX3911C 50MM EXT W/FEMALE V40 TAPER C-KM39-1-103 RX3911D 60MM EXT W/FEMALE V40 TAPER C-KM40-1-301 RX4013B 40MM EXT W/FEMALE V40 TAPER C-KM40-1-302 RX4013C 50MM EXT W/FEMALE V40 TAPER C-KM40-1-303 RX4013D 60MM EXT W/FEMALE V40 TAPER C-KM40-6-400 RX4064A 40MM EXT W/FEMALE V40 TAPER C-KM40-7-301 RX4073B 40MM EXT W/FEMALE V40 TAPER C-KM40-7-302 RX4073C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-501 RX4095B 40MM EXT W/FEMALE V40 TAPER C-KM40-9-502 RX4095C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-503 RX4095D 60MM EXT W/FEMALE V40 TAPER C-KM41-3-001 RX4130B 40MM EXT W/FEMALE V40 TAPER C-KM41-3-002 RX4130C 50MM EXT W/FEMALE V40 TAPER C-KM41-3-003 RX4130D 60MM EXT W/FEMALE V40 TAPER C-KM41-6-401 RX4164B 40MM EXT W/FEMALE V40 TAPER C-KM41-6-402 RX4164C 50MM EXT W/FEMALE V40 TAPER C-KM41-6-403 RX4164D 60MM EXT W/FEMALE V40 TAPER C-KM42-7-902 RX4279C 50MM EXT W/FEMALE V40 TAPER C-KM42-7-903 RX4279D 60MM EXT W/FEMALE V40 TAPER C-KM43-0-401 RX4304B 40MM EXT W/FEMALE V40 TAPER C-KM43-0-402 RX4304C 50MM EXT W/FEMALE V40 TAPER C-KM43-0-403 RX4304D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-201 RX4312B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-202 RX4312C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-203 RX4312D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-301 RX4313B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-302 RX4313C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-303 RX4313D 60MM EXT W/FEMALE V40 TAPER C-KM43-2-101 RX4321B 40MM EXT W/FEMALE V40 TAPER C-KM43-4-900 RX4349A 50MM EXT W/FEMALE C-TAPER C-KM43-4-901 RX4349B 60MM EXT W/FEMALE C-TAPER C-KM43-5-901 RX4359B 40MM EXT W/FEMALE V40 TAPER C-KM43-5-902 RX4359C 50MM EXT W/FEMALE V40 TAPER C-KM43-5-903 RX4359D 60MM EXT W/FEMALE V40 TAPER C-KM43-7-901 RX4379B 40MM EXT W/FEMALE V40 TAPER C-KM43-7-902 RX4379C 50MM EXT W/FEMALE V40 TAPER C-KM43-7-903 RX4379D 60MM EXT W/FEMALE V40 TAPER C-KM43-9-501 RX4395B 40MM EXT W/FEMALE V40 TAPER C-KM43-9-502 RX4395C 50MM EXT W/FEMALE V40 TAPER C-KM43-9-503 RX4395D 60MM EXT W/FEMALE V40 TAPER C-KM44-1-701 RX4417B 40MM EXT W/FEMALE V40 TAPER C-KM44-1-702 RX4417C 50MM EXT W/FEMALE V40 TAPER C-KM44-1-703 RX4417D 60MM EXT W/FEMALE V40 TAPER C-KM44-2-701 RX4427B 40MM EXT W/FEMALE V40 TAPER C-KM44-2-702 RX4427C 50MM EXT W/FEMALE V40 TAPER C-KM44-2-703 RX4427D 60MM EXT W/FEMALE V40 TAPER C-KM45-1-801 RX4518B 40MM EXT W/FEMALE V40 TAPER C-KM45-1-802 RX4518C 50MM EXT W/FEMALE V40 TAPER C-KM45-1-803 RX4518D 60MM EXT W/FEMALE V40 TAPER C-KM46-9-301 RX4693B 40MM EXT W/FEMALE V40 TAPER C-KM50-2-202 RX5022C PAR FEM EXT C-TAPER 40MM C-KM50-2-203 RX5022D PAR FEM EXT C-TAPER 50MM C-KM50-2-204 RX5022E PAR FEM EXT C-TAPER 60MM C-KM50-4-102 RX5041C PAR 40MM EXT W/FEMALE V40 TAPE C-KM51-6-202 RX5162C PAR 40MM EXT W/FEMALE V40 TAPE C-M052-9-402 RX5294C PAR FEM EXT V40 40MM C-M053-2-202 RX5322C PAR FEM EXTENSION C-TAPER 40MM C-M053-2-203 RX5322D PAR FEM EXTENSION C-TAPER 50MM C-M053-2-204 RX5322E PAR FEM EXTENSION C-TAPER 60MM C-M054-3-202 RX5432C PAR EXTENTION 50MM V40 TAPER C-M054-3-203 RX5432D PAR EXTENSION 60MM V40 TAPER C-M054-9-902 RX5499C PAR EXTENSION V40 TAPER 40MM C-M055-2-603 RX5526D PAR FEMORAL EXTENSION V40 TAPE C-M055-2-604 RX5526E PAR FEMORAL EXTENSION V40 TAPE C-M055-3-402 RX5534C PAR FEMORAL EXT V40 TAPER 40MM C-M055-3-403 RX5534D PAR FEMORAL EXT V40 TAPER 50MM C-M055-3-404 RX5534E PAR FEMORAL EXT V40 TAPER 60MM C-M055-9-301 RX5593B TI PAR FEMORAL EXT V40 TAPER 4 C-M056-1-102 RX5611C PAR FEMORAL EXT V40 TAPER 40MM C-M056-1-103 RX5611D PAR FEMORAL EXT V40 TAPER 50MM C-M056-1-104 RX5611E PAR FEMORAL EXT V40 TAPER 60MM C-M056-4-202 RX5642C PAR FEM EXT V40 TAPER 40MM C-M056-4-203 RX5642D PAR FEM EXT V40 TAPER 50MM C-M056-4-204 RX5642E PAR FEM EXT V40 TAPER 60MM C-M059-1-202 RX05912C PAR FEM EXT V40 TAPER 40MM C-M062-2-601 RX06226B PAR FEM EXT C-TAPER 40MM C-M062-2-602 RX06226C PAR FEM EXT C-TAPER 50MM C-M062-2-603 RX06226D PAR FEM EXT C-TAPER 60MM C-M062-3-401 RX06234B PERI-ACETABULAR PROSTHESIS FEM C-M062-3-402 RX06234C PERI-ACETABULAR PROSTHESIS FEM C-M062-3-403 RX06234D PERI-ACETABULAR PROSTHESIS FEM C-M062-5-702 RX06257C PAR EXT V40 TAPER 40MM C-M062-5-703 RX06257D PAR EXT V40 TAPER 50MM C-M062-5-704 RX06257E PAR EXT V40 TAPER 60MM C-M062-8-500 RX06285A PAR FEMORAL EXT C-TAPER 60mm C-M062-9-202 RX06292C PAR FEMORAL EXT V40 TAPER 40MM C-M062-9-203 RX06292D PAR FEMORAL EXT V40 TAPER 50MM C-M062-9-204 RX06292E PAR FEMORAL EXT V40 TAPER 60MM C-M063-6-601 RX06366B PAR FEM EXT V40 TAPER 40MM C-M063-6-602 RX06366C PAR FEM EXT V40 TAPER 50MM C-M063-8-702 RX06387C PAR FEM EXT V40 TAPER 40MM C-M064-3-102 RX06431C PAR FEM EXT V40 TAPER 40MM C-M064-3-103 RX06431D PAR FEM EXT V40 TAPER 50MM C-M064-3-104 RX06431E PAR FEM EXT V40 TAPER 60MM C-M066-2-302 RX06623C PAR FEM EXT V40 TAPER 40MM C-M066-2-303 RX06623D PAR FEM EXT V40 TAPER 50MM C-M066-2-304 RX06623E PAR FEM EXT V40 TAPER 60MM C-M066-6-003 RX06660D PAR FEM EXT V40 TAPER 50MM C-M066-6-004 RX06660E PAR FEM EXT V40 TAPER 60MM C-M066-8-602 RX06686C PAR FEM EXT V40 TAPER 50MM C-M066-9-302 RX06693C PAR FEM EXT V40 TAPER 40MM C-M066-9-303 RX06693D PAR FEM EXT V40 TAPER 50MM C-M066-9-304 RX06693E PAR FEM EXT V40 TAPER 60MM C-M067-1-002 RX06710C PAR FEM EXT V40 TAPER 40MM C-M067-1-003 RX06710D PAR FEM EXT V40 TAPER 50MM C-M067-4-402 RX06744C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-403 RX06744D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-404 RX06744E PAR FEMORAL EXTENSION V40 TAPE C-M067-4-702 RX06747C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-703 RX06747D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-704 RX06747E PAR FEMORAL EXTENSION V40 TAPE C-M067-5-105 RX06571C PAR V-40 FEMORAL EXTENSION PI C-M067-5-106 RX06751D PAR V-40 FEMORAL EXTENSION PI C-M067-5-107 RX06751E PAR V-40 FEMORAL EXTENSION PI C-M068-0-902 MHM2LD PAR V-40 FEMORAL EXTENSION PI C-M068-0-903 MHM2LE PAR V-40 FEMORAL EXTENSION PI C-M068-0-904 MHM2LH PAR V-40 FEMORAL EXTENSION PI C-M068-2-402 MHM8YD PAR V40 FEMORAL EXTENSION 40MM C-M068-2-403 MHM8YE PAR V40 FEMORAL EXTENSION 50MM C-M068-6-902 MHN77T PAR V40 TAPER EXTENSION PIECE C-M068-6-903 MHN77V PAR V40 TAPER EXTENSION PIECE C-M068-6-904 MHN77W PAR V40 TAPER EXTENSION PIECE C-M068-7-402 MHN77X PAR V40 TAPER EXTENSION PIECE C-M068-7-403 MHN77Y PAR V40 TAPER EXTENSION PIECE C-M068-7-404 MHN780 PAR V40 TAPER EXTENSION PIECE C-M068-9-902 MHNYT1 PAR V40 TAPER EXTENSION PIECE C-M068-9-903 MHNYT2 PAR V40 TAPER EXTENSION PIECE C-M068-9-904 MHNYT3 PAR V40 TAPER EXTENSION PIECE C-M069-2-802 MHPKKL PAR FEM EXT V40 TAPER 60MM C-M069-4-004 MHRH4X PAR C-TAPER EXTENSION PIECE 60 C-M069-5-102 MHRARE PAR V40 TAPER EXTENSION PIECE C-M069-5-103 MHRARH PAR V40 TAPER EXTENSION PIECE C-M069-5-104 MHRARJ PAR V40 TAPER EXTENSION PIECE C-M069-5-602 MHR3DH PAR V40 TAPER EXTENSION PIECE C-M069-5-603 MHR3E0 PAR V40 TAPER EXTENSION PIECE C-M069-5-604 MHR3DX PAR V40 TAPER EXTENSION PIECE C-M070-0-400 MHTPHK PAR V40 FEMORAL EXTENSION COMP C-M071-4-501 MJMVKP V40 FEMORAL EXTENSION COMPONEN C-M071-4-502 MJM0MW V40 FEMORAL EXTENSION COMPONEN C-M071-4-503 MJM1N5 V40 FEMORAL EXTENSION COMPONEN C-M071-8-001 MJP1N6 V40 FEMORAL EXTENSION COMPONEN C-M071-8-801 MJPVJ4 V40 FEMORAL EXTENSION COMPONEN C-M071-8-802 MJPEPK V40 FEMORAL EXTENSION COMPONEN C-M071-8-803 MJP9T9 V40 FEMORAL EXTENSION COMPONEN C-M072-0-901 MJR51TA C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJR20A8 C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJRVXNA C-TAPER FEMORAL EXTENSION COMP C-M072-0-903 MJRPR1A C-TAPER FEMORAL EXTENSION COMP C-M078-6-002 MLDP0A PAR EXTENSION PIECE C-TAPER 40 C-M079-0-602 MLE6V3 V40 FEMORAL EXTENSION COMPONEN KM15-3-502 RX1535B FEMORAL EXTENSION COMP 60mm KM15-3-503 RX1535C FEMORAL EXTENSION COMP 80mm KM15-3-504 RX1535D FEMORAL EXTENSION COMP 100mm KM16-9-203 RX1692D 45mm FEMORAL EXTENSION KM16-9-205 RX1692E 60mm FEMORAL EXTENSION KM19-1-302 RX1913C FEMORAL EXT 'C' TAPER - 50mm KM19-1-303 RX1913D FEMORAL EXT 'C' TAPER - 60mm KM19-1-304 RX1913E FEMORAL EXT 'C' TAPER - 80mm KM20-4-102 RX2041C PAR EXTENSION C-TAPER 40mm KM20-4-103 RX2041D PAR EXTENSION C-TAPER 50mm KM20-4-104 RX2041E PAR EXTENSION C-TAPER 60mm KM20-5-701 RX2057B PAR FEM EXTENSION - 60mm KM21-2-402 RX2124C FEM EXTENSION C-TAPER 40mm PAR KM21-2-403 RX2124D FEM EXTENSION C-TAPER 50mm PAR KM21-2-404 RX2124E FEM EXTENSION C-TAPER 60mm PAR KM21-5-302 RX2153C PAR FEMORAL EXTENSION - 40MM KM21-5-303 RX2153D PAR FEMORAL EXTENSION - 50MM KM21-5-304 RX2153E PAR FEMORAL EXTENSION - 60MM KM21-6-802 RX2168C FEM EXTENSION C-TAPER 40mm PAR KM21-6-803 RX2168D FEM EXTENSION C-TAPER 50mm PAR KM21-6-804 RX2168E FEM EXTENSION C-TAPER 60mm PAR KM21-7-702 RX2177C PAR FEM EXTENSION V40 - 40MM KM21-7-703 RX2177D PAR FEM EXTENSION V40 - 50MM KM21-7-704 RX2177E PAR FEM EXTENSION V40 - 60MM KM21-7-901 RX2179E PAR LOCKING SCREW KM21-7-902 RX2179C PAR FEMORAL EXTENSION - 40MM KM21-7-903 RX2179D PAR FEMORAL EXTENSION - 50MM KM21-9-402 RX2194C PAR FEM EXT C-TAPER 40MM KM21-9-403 RX2194D PAR FEM EXT C-TAPER 60MM KM21-9-404 RX2194E PAR FEM EXT C-TAPER 50MM KM21-9-405 RX2194F PAR FEM EXT 40MM KM21-9-406 RX2194G PAR FEM EXT 50MM KM21-9-407 RX2194H PAR FEM EXT 60MM KM22-8-702 RX2287C FEM EXTENSION C-TAPER 40mm PAR KM22-8-703 RX2287D FEM EXTENSION C-TAPER 50mm PAR KM22-8-704 RX2287E FEM EXTENSION C-TAPER 60mm PAR KM23-6-702 RX2367C PAR FEM EXT 40MM V40 KM23-6-703 RX2367D PAR FEM EXT 50MM V40 KM23-6-704 RX2367E PAR FEM EXT 60MM V40 KM23-7-403 RX2374D PAR FEM EXT 50MM V40 KM23-7-404 RX2374E PAR FEM EXT 60MM V40 KM23-7-503 RX2375D PAR FEM EXT 50MM V40 KM23-7-504 RX2375E PAR FEM EXT 60MM V40 KM23-7-902 RX2379C PAR FEM EXT 40MM V40 KM23-7-903 RX2379D PAR FEM EXT 50MM V40 KM23-7-904 RX2379E PAR FEM EXT 60MM V40 KM24-5-902 RX2459C PAR FEM EXTENSION V40 - 40MM KM24-5-903 RX2459D PAR FEM EXTENSION V40 - 50MM KM24-5-904 RX2459E PAR FEM EXTENSION V40 - 60MM KM26-0-902 RX2609C PAR FEM EXT 40MM FEM C-TAPER KM26-0-903 RX2906D PAR FEM EXT 50MM FEM C-TAPER KM26-0-904 RX2906E PAR FEM EXT 60MM FEM C-TAPER KM27-6-402 RX2764C PAR FEM EXT 40MM FEM C-TAPER KM27-6-403 RX2764D PAR FEM EXT 50MM FEM C-TAPER KM27-6-404 RX2764E PAR FEM EXT 60MM FEM C-TAPER KM28-3-700 RX3837A PAR FEM EXT - 80MM - V40 TAPER P-KM11-0-503 KM1105N6 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N9 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N7 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N31 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N51 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N41 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N81 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N101 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 X1105Q2 PAR FEMORAL EXTENSION 60MM P-KM11-0-504 KM1105D11 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D41 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D2 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D7 PAR FEMORAL EXTENSION 80MM P-KM11-0-505 KM1105E11 PAR FEMORAL EXTENSION 100MM P-KM11-0-505 KM1105E2 PAR FEMORAL EXTENSION 100MM Class II Stryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem. Stryker Howmedica Osteonics Corp.
Devices HX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116. Class II Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. Terumo Cardiovascular Systems Corporation
Devices Tested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit. Catalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05. Class II Based on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual. Terumo Cardiovascular Systems Corporation
Devices Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. Lot 1108-01 Class II Some of the sterile packages had broken seals. Progressive Medical Inc
Devices Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening. Part number 390.007, Lot number 6800599 Class II The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. Synthes USA HQ, Inc.
Devices ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. Catalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA Class II Zimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the control board. Zimmer, Inc.
Devices ABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer. Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. Class III This recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay. Horiba Instruments, Inc dba Horiba Medical
Devices TriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm The following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01 Class II Selected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in the patient. Trivascular, Inc
Devices Select Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination. Lot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635. Class II Gulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale. Gulf South Medical Supply Inc
Devices EnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications. INFKIT2 with serial numbers: 506249031, 506264096, 506272024, 506335006, 506335145, 506336089, 506336096, 506362083, 506362086, 507018037, 507018060, 507067220, 507085140, 507087018, 507087140, 507095089, 507095171, 507121102, 507122050, 507122066, 507123149, 507123163, 507144016, 507144057, 507144215, 507144220, 507144221, 507144226, 507151002, 507155019, 507155021, 507155094, 507155127, 507155156, 507155159, 507156065, 507157048, 507157124, 507164009, 507173005, 507173019, 507173063, 507179123, 507180064, 507186018, 507186098, 507186176, 507197012, 507197024, 507197036, 507201013, 507201038, 507205054, 507206064, 507212012, 507212013, 507214065, 507214098, 507214162, 507215041, 507218016, 507219057, 507219087, 507219103, 507220106, 507221098, 507227116, 507229033, 507229039, 507229060, 507232030, 507236063, 507236203, 507236303, 507239056, 507241089, 507242130, 507242201, 507247049, 507248031, 507248087, 507248095, 507249131, 507250175, 507255025, 507257123, 507257129, 507261065, 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511076054, 511076055, 511076056, 511076057, 511076058, 511076059, 511076060, 511076061, 511076062, 511076063, 511076064, 511076065, 511076066, 511076067, 511076068, 511076069, 511076070, 511076071, 511076072, 511076073, 511076074, 511076075, 511076076, 511076077, 511076078, 511076079, 511076080, 511076081, 511076082, 511076083, 511076084, 511076085, 511076086, 511076087, 511076088, 511076089, 511076090, 511076091, 511076092, 511076093, 511076094, 511076095, 511076096, 511076097, 511076098, 511076099, 511076100, 511076101, 511076102, 511076103, 511076104, 511076105, 511076106, 511076107, 511076108, 511076109, 511076110, 511076111, 511076112, 511076113, 511076114, 511076115, 511076116, 511076117, 511076118, 511076119, 511076120, 511076121, 511076122, 511076123, 511076124, 511076125, 511076126, 511076127, 511076128, 511076129, 511076130, 511076131, 511076132, 511076133, 511076134, 511076135, 511076136, 511076137, 511076138, 511076139, 511076140, 511076141, 511076142, 511076143, 511076144, 511076145, 511076146, 511076147, 511076148, 511076149, 511076150, 511076151, 511076152, 511076153, 511076154, 511076155, 511076156, 511076157, 511076158, 511076159, 511076160, 511076161, 511076162, 511076163, 511076164, 511076165, 511076166, 511076167, 511076168, 511076169, 511076170, 511076171, 511076172, 511076173, 511076174, 511076175, 511076176, 511076177, 511076178, 511076179, 511076180, 511077001, 511077002, 511077003, 511077004, 511077005, 511077006, 511077007, 511077008, 511077009, 511077010, 511077011, 511077012, 511077013, 511077014, 511077015, 511077016, 511077017, 511077018, 511077019, 511077020, 511077022, 511077023, 511077024, 511077025, 511077026, 511077027, 511077028, 511077029, 511077030, 511077031, 511077032, 511077033, 511077034, 511077035, 511077036, 511077037, 511077038, 511077039, 511077040, 511077041, 511077042, 511077043, 511077044, 511077045, 511077046, 511077047, 511077048, 511077049, 511077050, 511077051, 511077052, 511077053, 511077054, 511077055, 511077056, 511077057, 511077058, 511077059, 511077060, 511077061, 511077062, 511077063, 511077064, 511077065, 511077066, 511077067, 511077068, 511077069, 511077070, 511077071, 511077072, 511077073, 511077074, 511077075, 511077076, 511077077, 511077078, 511077079, 511077080, 511077081, 511077082, 511077083, 511077084, 511077085, 511077086, 511077087, 511077088, 511077089, 511077090, 511077091, 511077092, 511077093, 511077094, 511077095, 511077096, 511077097, 511077098, 511077099, 511077100, 511077101, 511077102, 511077103, 511077104, 511077105, 511077106, 511077107, 511077108, 511077109, 511077110, 511077111, 511077112, 511077113, 511077114, 511077115, 511077116, 511077117, 511077118, 511077119, 511077120, 511077121, 511077122, 511077123, 511089001, 511089002, 511089003, 511089004, 511089005, 511089006, 511089007, 511089008, 511089009, 511089010, 511089011, 511089012, 511089013, 511089014, 511089015, 511089016, 511089017, 511089018, 511089019, 511089020, 511089021, 511089022, 511089023, 511089024, 511089025, 511089026, 511089027, 511089028, 511089029, 511089030, 511089031, 511089032, 511089033, 511089034, 511089035, 511089036, 511089037, 511089038, 511089040, 511089041, 511089042, 511089043, 511089044, 511089045, 511089046, 511089047, 511089048, 511089049, 511089050, 511089051, 511089052, 511089053, 511089054, 511089055, 511089056, 511089057, 511089058, 511089059, 511089060, 511089061, 511089062, 511089063, 511089064, 511089065, 511089066, 511089067, 511089068, 511089069, 511089070, 511089071, 511089072, 511089073, 511089074, 511089075, 511089076, 511089077, 511089078, 511089079, 511089080, 511089081, 511089082, 511089083, 511089084, 511089085, 511089086, 511089087, 511089088, 511089089, 511089090, 511089091, 511089092, 511089093, 511089094, 511089095, 511089096, 511089097, 511089098, 511089099, 511089100, 511089101, 511089102, 511089103, 511089104, 511089105, 511089106, 511089107, 511089108, 511089109, 511089110, 511089111, 511089112, 511089113, 511089115, 511089116, 511089117, 511089118, 511089119, 511089120, 511089121, 511089122, 511089123, 511089124, 511089125, 511089126, 511089127, 511089128, 511089129, 511089130, 511089131, 511089132, 511089133, 511089134, 511089135, 511089136, 511089137, 511089138, 511089139, 511089140, 511089141, 511089142, 511089143, 511089144, 511089145, 511089146, 511089147, 511089148, 511089149, 511089150, 511089151, 511089152, 511089153, 511089154, 511089155, 511089156, 511089157, 511089158, 511089159, 511089160, 511089161, 511089162, 511089163, 511089164, 511089165, 511089166, 511089167, 511089168, 511089169, 511089170, 511089171, 511089172, 511089173, 511089174, 511097001, 511097002, 511097003, 511097004, 511097006, 511097007, 511097008, 511097009, 511097010, 511097011, 511097012, 511097013, 511097014, 511097015, 511097016, 511097017, 511097018, 511097019, 511097020, 511097021, 511097022, 511097023, 511097024, 511097025, 511097026, 511097027, 511097028, 511097029, 511097030, 511097031, 511097032, 511097033, 511097034, 511097035, 511097036, 511097037, 511097038, 511097039, 511097040, 511097041, 511097042, 511097043, 511097044, 511097045, 511097046, 511097047, 511097048, 511097049, 511097050, 511097051, 511097052, 511097053, 511097054, 511097055, 511097056, 511097057, 511097058, 511097059, 511097060, 511097061, 511097062, 511097063, 511097064, 511097065, 511097066, 511097067, 511097068, 511097069, 511097070, 511097071, 511097072, 511097073, 511097074, 511097075, 511097076, 511097077, 511097078, 511097079, 511097080, 511097081, 511097083, 511097084, 511097085, 511097086, 511097087, 511097088, 511097089, 511097090, 511097091, 511097092, 511097093, 511097094, 511097095, 511097096, 511097097, 511097098, 511097099, 511097100, 511097101, 511097102, 511097103, 511097104, 511097105, 511097106, 511097107, 511097108, 511097109, 511097110, 511097111, 511097112, 511097113, 511097114, 511097115, 511097116, 511097117, 511097118, 511097119, 511097120, 511097121, 511097122, 511097123, 511097124, 511097125, 511097126, 511097127, 511097128, 511097129, 511103001, 511103002, 511103003, 511103004, 511103005, 511103006, 511103007, 511103008, 511103009, 511103010, 511103011, 511103012, 511103013, 511103014, 511103015, 511103016, 511103017, 511103018, 511103019, 511103020, 511103021, 511103022, 511103023, 511103024, 511103025, 511103026, 511103027, 511103028, 511103029, 511103030, 511103031, 511103032, 511103033, 511103034, 511103035, 511103036, 511103037, 511103038, 511103039, 511103040, 511103041, 511103042, 511103043, 511103044, 511103045, 511103046, 511103047, 511103048, 511103049, 511103050, 511103051, 511103052, 511103053, 511103054, 511103055, 511103056, 511103057, 511103058, 511103059, 511103060. INFORNG with serial numbers: 608164025, 609065045, 610036056, 610216015, 610216042, 610244002, 610244003, 610244004, 610244005, 610244006, 610244007, 610244008, 610244009, 610244011, 610244012, 610244013, 610244014, 610244015, 610244016, 610244017, 610244018, 610244019, 610244020, 610244021, 610244022, 610244023, 610244024, 610244025, 610244026, 610244027, 610244028, 610244029, 610244030, 610244031, 610244032, 610244033, 610244034, 610244035, 610244036, 610244037, 610244038, 610244039, 610244040, 610244041, 610244042, 610244043, 610244044, 610244045, 610244046, 610244047, 610244048, 610244049, 610244050, 610244051, 610244052, 610244053, 610244054, 610321001, 610321002, 610321003, 610321004, 610321005, 610321006, 610321007, 610321008, 610321009, 610321010, 610321011, 610321012, 610321013, 610321014, 610321015, 610321016, 610321017, 610321018, 610321019, 610321020, 610321021, 610321022, 610321023, 610321024, 610321025, 610321026, 610321027, 610321028, 610321029, 610321030, 610321031, 610321034, 610321035, 610321036, 610321037, 610321038, 610321039, 610321040, 610321041, 610321042, 610321043, 610321044, 610321045, 610321046, 610321047, 610321048, 610321049, 610321050, 610321051, 610321052, 610321053, 610321054, 610321055, 610321056, 610321057, 610321058, 610321059, 610321060, 610321061, 610321062, 610321063, 610321064, 610336001, 610336002, 610336003, 610336004, 610336005, 610336006, 610336007, 610336008, 610336009, 610336010, 610336011, 610336012, 610336013, 610336014, 610336015, 610336016, 610336017, 610336018, 610336019, 610336020, 610336021, 610336022, 610336023, 610336024, 610336025, 610336026, 610336027, 610336028, 610336029, 610336030, 610336031, 610336032, 610336033, 610336034, 610336035, 610336036, 610336037, 610336038, 610336039, 610336040, 610336041, 610336042, 610336043, 610336044, 610336045, 610336046, 610336047, 610336048, 610336049, 610336050, 610336051, 610336052, 610336053, 610336054, 610336055, 610336056, 610336057, 610336058, 610336059, 610336060, 610354001, 610354002, 610354003, 610354004, 610354005, 610354006, 610354007, 610354008, 610354009, 610354010, 610354011, 610354012, 610354013, 610354014, 610354015, 610354016, 610354017, 610354018, 610354019, 610354020, 610354021, 610354022, 610354023, 610354024, 610354025, 610354026, 610354027, 610354028, 610354029, 610354030, 610354031, 610354032, 610354033, 610354034, 610354035, 610354036, 610354037, 610354038, 610354039, 610354040, 610354041, 610354042, 610354043, 610354044, 610354045, 611054001, 611054002, 611054003, 611054004, 611054005, 611054006, 611054007, 611054008, 611054009, 611054010, 611054011, 611054012, 611054013, 611054014, 611054015, 611054016, 611054017, 611054018, 611054019, 611054020, 611054021, 611054022, 611054023, 611054024, 611054025, 611054026, 611054027, 611054028, 611054029, 611054030, 611054031, 611054032, 611054033, 611054034, 611054035, 611054036, 611054037, 611054038, 611054039, 611054040, 611054041, 611054042, 611054043, 611054044, 611054045, 611054046, 611054047, 611054048, 611054049, 611054050, 611054051, 611054052, 611054053, 611081001, 611081002, 611081003, 611081004, 611081005, 611081006, 611081007, 611081008, 611081009, 611081010, 611081011, 611081012, 611081013, 611081014, 611081015, 611081016, 611081017, 611081018, 611081019, 611081020, 611081021, 611081022, 611081023, 611081024, 611081025, 611081026, 611081027, 611081028, 611081029, 611081030, 611081031, 611081032, 611081033, 611081034, 611081035, 611081036, 611081037, 611081038, 611081039, 611081040, 611081041, 611081042, 611081043, 611081044, 611081045, 611081046, 611081047, 611081048, 611081049. Class II MOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely. MOOG Medical Devices Group

WEEK ENDING NOVEMBER 17

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3300E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures. Serial Numbers: 330001-330069, 330071, 330072, 330074, 330075. Class II Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. Sechrist Industries Inc
Devices Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model 3600E/ER The Hyperbaric Chamber is intended to provide 100% oxygen to the patient at greater than ambient pressures Serial Numbers: 360001-360049, 360051-360064, 360068. Class II Sechrist conducted a field upgrade on the hyperbaulic chambers equipped with Electronic Control Modules in order to correct a software bug that could potentially affect the performance of the chamber. Sechrist Industries Inc
Devices Quadra S Offset Broach Handle The offset broach handle is intended to attach to the broaches of different sizes as the surgeon broaches the femoral bone in preparation for the implantation of the femoral stem. Ref: 01.10.10.122 (Lot # 085119), Ref: 01.10.10.123 (Lot # 085120), Ref: 01.10.10.124 (Lot # 085244), Ref: 01.10.10.125 (Lot # 085243) Class II Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle because of the potential of the rivet that locks the metallic wire to the lever may become loose during a surgery and make it impossible to lock/unlock the broaches. Medacta Usa Inc
Devices R-30H , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-ray tubes 0.6/1.2P364DK-85, 0.6/1.2P324DK-125, 0.6/1.2P324DK-85, 0.6/1.2P38DE-85 Device Model # R-30H. Subsequent Product Code: IZX Product Usage: The device is the beam-limiting device for X-ray Radiography. Device Model #R-30H Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices R-20J , Diagnostic X-Ray Beam-Limiting Device. In combination with any of below X-Ray tubes: 06/1.2P364DK-85, 0.6/1.2P324DK-125, 06/1.2P324DK-85, 0.6/1.2P38DE-85. Product Usage: The device is the beam-limiting device for X-ray Radiography. Device Model #R-20J Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7U163CS-36 In combination with below systems MUX-100H, MUX-100D, MobileArt Evolution Brand Name: MUX-100H. Classification Name: Mobile x-ray system. Device Model#MUX-100H. Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 63049 63048 63074 63081 63082 63077 63350 63349 63629 63647 63909 62729 64214 66033 66032 70070 70065 70364 66327 66331 70058 66325 70955 71241 70920 71848 72472 72462 73056 73058 73341 73675 74577 74563 74565 74557 74558 74846 74845 75455 75452 75457 75728 75737 75736 76059 76057 76060 76054 76062 76360 76366 76612 76636 76336 76916 76655 76647 76938 76940 2XY080646 2XY0081249 2XY0081245 2XY0081543 2XY0081858 2XY0081849 2XY0081855 2XY0081856 2XY0081865 2XY0081862 2XY0082746 2XY0082764 2XY0083055 2XY0083052 2XY0083064 2XY0083051 2XY0083053 2XY0083038 2XY0083063 2XY0083063 2XY0083065 2XY0083343 2XY0083340 2XY0083349 2XY0083354 2XY0083360 2XY0083355 2XY0083646 2XY0083359 2XY0083652 2XY0083670 2XY0083674 2XY0083655 2XY0083673 2XY0083675 2XY0083665 2XY0083645 2XY0083643 2XY0083629 2XY0074577 2XY0083638 2XY0083943 2XY0083671 2XY0083933 2XY0083930 2XY0083925 2XY0084532 2XY0084558 2XY0084546 2XY0084553 2XY0084538 2XY0084846 2XY0084565 2XY0084845 2XY0085124 2XY0085137 2XY0085127 2XY0084578 2XY0085140 2XY0085143 2XY0085141 2XY0086351 2XY0084860 2XY0084856 2XY0084851 2XY0084859 2XY0086344 2XY0084852 2XY0086365 2XY0086364 2XY0086373 2XY0086368 2XY0086665 2XY0086674 2XY0087077 2XY0087371 2XY0087044 2XY0087036 2XY0087041 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7/1.3U163CS-36 In combination with below systems MobileArt Evolution, MobileDaRt Evolution Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 64510 66036 66026 66027 71866 70641 72470 72740 72735 73360 73365 2XY0084531 73372 73679 73671 73966 74248 74258 74546 74548 74291 74556 74832 74834 74833 74829 74837 76058 76326 76069 76355 76364 76361 76356 76358 76363 76367 2XY0080666 80666 2XY0080650 2XY0080345 2XY0080649 2XY0080656 2XY0082453 2XY0082456 2XY0082461 2XY0082748 2XY0083039 2XY0075448 2XY0082750 2XY0083070 2XY0082778 2XY0083047 2XY0083058 2XY0083680 2XY0083627 2XY0083633 2XY0083951 2XY0084556 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.7/1.2JG326D-265 Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. MobileArt Evolution (12.5 kW) S/N of X-ray tube: 2XY0090049 2XY0090052 2XY0090062 2XY0090388 2XY0092824 2XY0092822 2XY0094944 2XY0094940 2XY0095628 2XY0095975 2XY0095996 2XY0097550 2XY0097539 2XY0000035 2XY0090058 MobileArt Evolution (32 kW) S/N of X-ray tube: 2XY0092847 2XY0092851 2XY0092850 2XY0093893 2XY0093890 2XY0093561 2XY0096822 2XY0096828 2XY0097579 2XY0000834 2XY0001079 2XY0001215 2XY0001200 2XY0001311 2XY0001216 2XY0001312 2XY0001214 2XY0001377 2XY0001374 2XY0001383 2XY0001488 2XY0001653 2XY0001478 2XY0001657 2XY0001658 2XY0001674 2XY0001672 2XY0001644 2XY0002081 2XY0002281 2XY0002088 2XY0002083 2XY0002289 2XY0001827 CM74B3012026 2XY0003774 2XY0004043 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices 0.4/0.7JG326D-265AX/AT Product Usage: The device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of outpatients in emergency. S/N of X-ray tube: 2XY0084725 2XY0084724 2XY0084723 2XY0099698 2XY0084726 2XY0084736 2XY0084739 2XY0084869 2XY0084729 2XY0084868 2XY0085162 2XY0085175 2XY0086383 2XY0086395 2XY0086726 2XY0086725 2XY0086724 2XY0087086 2XY0087088 2XY0087090 2XY0087421 2XY0087423 2XY0087427 2XY0087765 2XY0090747 2XY0091075 2XY0093894 2XY0096298 2XY0096820 2XY0096821 2XY0096832 2XY0096292 2XY0098245 2XY0098240 2XY0001064 2XY0001195 2XY0001088 2XY0001208 2XY0001077 2XY0001086 2XY0001198 2XY0001321 2XY0001204 2XY0001336 2XY0001337 2XY0001352 2XY0001388 2XY0001315 2XY0001370 2XY0001380 2XY0001464 2XY0001482 2XY0001484 2XY0001485 2XY0002730 2XY0003042 2XY0003037 2XY0003759 CM74B3016024 CM74B3017067 CM74B301201A CM74B3012018 CM74B3012017 CM74B301201C CM74B3012020 CM74B3012034 CM74B3012032 CM74B3013002 CM74B3016073 CM74B3016109 CM74B3015010 Class II Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile x-ray system and Diagnostic x-ray tube assembly because they do not comply with the Product Performance Standards, 21CFR 1020.30 (m) Beam quality --(1) Half-value layer (HVL), which was revised in 2006. Certain devices might not comply with the requirements for them in some x-ray generating condition after the revision in 2006. Shimadzu Medical Systems
Devices Sysmex XE-2100 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #983-1341-1 The Sysmex XE-2100 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-2100 performs hematology analyses according to the RF/DC detection method, HydroDynamic Focusing (DC Detection), flow cytometry method (using a semiconductor laser), and SLS-hemoglobin method. catalog #983-1341-1, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Devices Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The XE-5000 performs analyses using the following methods: RF/DC Detection Method, Sheath Row DC Detection Method, and Flow Cytometry Methods using a Semiconductor Laser. Particle characterization and identification is based on detection of forward scatter, fluorescence and adaptive cluster analysis. Using the same reagents as the XE-2100, the XE-5000 automatically classifies cells from blood and body fluids and carries out all processes automatically from aspiration of the sample to outputting the results. catalog #063-7591-7, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Devices Sysmex XE-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. catalog ##053-2311-4, all serial numbers Class II There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias. Sysmex America, Inc.
Devices Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic test for the quantitative measurement of total homocysteine (HCYS) in human serum, heparinized plasma, and EDTA plasma on the Dimension Vista(R) System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Lot numbers 12062MA, exp 12/01/2012; and 12066MA, exp 12/05/2012 Class III Cartridges are leaking. The leaking is observed when opening the wrapper that holds the reagent cartridge. Siemens Healthcare Diagnostics, Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2740***" Ophthalmic surgery MAFD350, M381400, M407870, M439070, M439090, M466140, M495140, M495190, M510800, M554700, M554740, M585650, M656720, M656730, MABL380, MABQ000, MADM740 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-2840***" Ophthalmic surgery M342500, M342510, M415840, M439130, M446040, M495130, M495160, M510810, M553460, M553470, M553480, M585640, M585740, M652760, M652770, M652780, MADP160, MADP170 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3040***" Ophthalmic surgery MABQ150, MAGS310, MAJC690 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices "***Sharpoint IQ Geometry Slit Knife Angled, Bevel Up***Surgical Specialties Corporation Reading, PA***REF 72-3240***" Ophthalmic surgery MAKR840, MALZ570, MALZ580, MAMQ990, MAMR000, MANP250, MAPR320, MAQD910 Class II Potential for bent tips. Surgical Specialties Puerto Rico Inc. dba Angiotech PR Inc.
Devices AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus Medical LLC, 8401 Southern Blvd, Boardman, OH 44512. Usage: Hospital Bed. Model #TL500; Serial Number: 001, 002, 003, 004, 005, 006, 007, 010, 013, 014, 015, 016, 017, 018, 021, 022, 023, 024, 025, 026, 027, 028, 029, 030, 031, 032, 033, 034, 035, 039, 040, 041, 042, 043, 044, 045, 046, 047, 048, 049, 050, 052, 053, 054, 055, 056, 057, 058, 059, 060, 061, 062, 063, 064, 065, 070, 075, 081, 09350014, 09350015, 09350016, 09350017, 09350018, 09350021, 09350023, 09350025, 09350026, 09350027, 09350028, 09350029, 09350030, 09350031, 09350032, 09350033, 09350035, 09350038, 09350040, 09350041, 09350042, 09350045, 09350048, 09350049, 09350054, 09350055, 09350056, 09350057, 09350058, 09350059, 09350060, 09350062, 09350063, 09350064, 09350065, 09350066, 09350067, 09350068, 09350069, 09350070, 09350072, 09350074, 09350082, 09350085, 09350087, 09350088, 09350089, 09350090, 09350091, 09350092, 09430001, 09430002, 09430003, 09430004, 09430005, 09430006, 09430007, 09430008, 09430010, 09430013, 09430014, 09430015, 09430017, 09430019, 09430020, 09430021, 09430022, 09430024, 09430026, 09430027, 09430028, 09430029, 09430030, 09430032, 09430033, 09430034, 09430036, 09430037, 09430038, 09430039, 09430040, 09430041, 09430042, 09430043, 09430044, 09430045, 09430046, 09430047, 09430049, 09430050, 09430051, 09430052, 09430053, 09430054, 09430056, 09430057, 09430058, 09430059, 09430060, 09430061, 09430062, 09430063, 09430065, 09430066, 09463067, 09430068, 09430069, 09430070, 09430071, 09430072, 09430074, 09430075, 09430076, 09430077, 09430078, 09430079, 09430080, 09430081, 09430083, 09430085, 09430086, 09430087, 09430088, 09430089, 09430091, 09430093, 09430094, 09430097, 09430099, 09430100, 09520001, 09520002, 09520003, 09520004, 09520005, 09520006, 09520007, 09520008, 09520009, 09520011, 09520012, 09520013, 09520015, 09520017, 09520018, 09520019, 09520020, 09520021, 09520022, 09520025, 09520026, 09520027, 09520028, 09520029, 09520030, 09520031, 09520032, 09520033, 09520034, 09520035, 09520036, 09520037, 09520038, 09520039, 09520040, 09520041, 09520042, 09520043, 09520044, 09520045, 09520046, 09520047, 09520048, 09520049, 09520050, 10040001, 10040003, 10040004, 10040005, 10040006, 10040007, 10040008, 10040009, 10040010, 10040011, 10040012, 10040013, 10040014, 10040015, 10040016, 10040017, 10040028, 10040029, 10040030, 10040032, 10040033, 10040034, 10040035, 10040036, 10040037, 10040038, 10040039, 10040040, 10040041, 10040042, 10040043, 10040044, 10040045, 10040046, 10040047, 10040048, 10040049, 10040050, 10040051, 10040052, 10040053, 10040054, 10040055, 10040056, 10040057, 10040058, 10040059, 10040062, 10040063, 10040064, 10040065, 10040066, 10040067, 10040068, 10040069, 10040070, 10040071, 10040073, 10040074, 10040075, 10040076, 10040077, 10040078, 10400029, 10400050, 10400056, 10400057, 10400058, 10400059, 10400065, 10370016, 10370017, 10370018, 10370019, 10370020, 10370032, 10370033, 10370034, 10370035, 10370038, 10370052, 10370053, 10370054, 10370056, 10370060, 10370063, 10370078, 10370079, 10370080 , 09380031, 09380029, 09380064, 09380070, 09380089, 09380040, 09380038, 09380085, 09380045, 09380054, 09380060, 09380059, 09380058, 09380048, 09380042, 09380038, 09380069, 09380063, 09380067 & 09380065. Class II The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may fail under certain circumstances. The pins at the top of the leg were disengaging from the channel. This may cause the bed frame to come off tracks or collapse. Primus Medical LLC
Devices Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product part 501-605, Lot #1005-549 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product part 501-607, Lot #1005-549 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part 501-605, Lot #1005-549 and Product part 501-607, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and RDW% recovered for Boule Con-Diff Tri pack Lot 1005-549 were low and out of the assay range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 501-605, Lot #1102-575 and Lot # 1102-576 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 501-607, Lot #1102-576 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Product Part 502-012, Lot #1102-574 Class III Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part 501-605, Lot #1102-575 and 1102-576; Product Part 501-607, Lot #1102-576; and Product Part 502-012, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the receipt of a complaint stating the MCHC parameter of the Low Control of Boule Con-Diff US Tri Pack lot number 1102-575 recovered low and out of range. Clinical Diagnostic Solutions
Devices Alloclassic SL Shaft Item 2839, 2840, 2841, 2842, 2843, 2844, 2845, 2846, 2847, 2848, 2949, 2851, 2852, 2883, 2884, 2885, 2886, and 2887 Lots: 2359249, 2359251, 2359251, 2368739, 2413914, 2413914, 2426010, 2526138, 2335608, 2381324, 2387449, 2388541, 2401237, 2401237, 2492774, 2523553, 2355767, 2355767, 2361511, 2361511, 2371517, 2376476, 2440672, 2453100, 2479736, 2498363, 2529208, 2303302, 2347856, 2355765, 2355765, 2428247, 2428247, 2446699, 2456353, 2497037, 2506067, 2506067, 2509374, 2517494, 2316056, 2326792, 2335862, 2355428, 2370478, 2376478, 2382854, 2388539, 2391204, 2428742, 2431991, 2439733, 2453093, 2301633, 2343382, 2363829, 2363829, 2363829, 2370490, 2492887, 2513725, 2513725, 2513725, 2515404, 2515404, 2517796, 2529231, 2319316, 2340681, 2345324, 2359179, 2359179, 2413790, 2432646, 2479750, 2501280, 2509376, 2509376, 2509378, 2510392, 2510392, 2303201, 2333704, 2340906, 2368928, 2375002, 2388530, 2403651, 2445551, 2471087, 2507375, 2511623, 2523569, 2345382, 2396573, 2428657, 2432681, 2464083, 2469537, 2475899, 2529943, 2421855, 2421855, 2437494, 2437494, 2475746, 2475746, 2526284, 2391015, 2391015, 2391015, 2390171, 2418766, 2397095, 2399625, 2352268, 2406373, 2406373, 2437316, and 2518394 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Biolox® delta Ceramic Femoral Head Rx only, sterile REF Numbers: 00-8775-028-01, 00-8775-028-02, 00-8775-028-03, 00-8775-032-01, 00-8775-032-02, 00-8775-032-03, 00-8775-032-04, 00-8775-036-01, 00-8775-036-02, 00-8775-036-03, 00-8775-036-04, 00-8775-040-01, 00-8775-040-02, 00-8775-040-03, and 00-8775-040-04. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Biolox® Option Ceramic Femoral Head System Rx, sterile REF Numbers: 00-8777-028-02, 00-8777-036-01, 00-8777-036-02, and 00-8777-040-01. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Wagner SL Revision Stem, uncemented Sterile REF Numbers: 01.00101.914, 01.00101.915, 01.00101.916, 01.00101.917, 01.00101.918, 01.00102.217, 01.00102.219, 01.00102.221, 01.00102.619, 01.00102.620, 01.00102.621, 01.00102.622, 01.00103.015, 01.00103.017, 01.00103.021, 01.00103.025, 30.00.89.160, and 30.00.89.190. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Alloclassic® SL-Offset Stem sterile, Rx REF Numbers: 01.00121.020, 01.00121.030, 01.00121.040, 01.00121.050, 01.00121.060, 01.00121.070, and 01.00121.090. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Metasul® LDH® Head Rx Sterile REF Numbers: 01.00181.380, 01.00181.400, 01.00181.420, 01.00181.440, 01.00181.460, 01.00181.480, 01.00181.500, 01.00181.520, 01.00181.540, 01.00181.560, 01.00181.580, 01.00181.600, Lots:2336407, 2384226, 2417501, 2379463, 2414200, 2435636, 2437758, 2437758, 2439049, 2318066, 2318066, 2318066, 2337823, 2341591, 2341591, 2350267, 2350642, 2356116, 2379464, 2393154, 2393154, 2407029, 2417505, 2417505, 2334410, 2337816, 2337817, 2342259, 2350644, 2356119, 2356129, 2357620, 2357620, 2367367, 2414126, 2417566, 2431247, 2458307, 2470473, 2314684, 2330846, 2330846, 2331024, 2331024, 2331024, 2336380, 2337812, 2341474, 2341474, 2341474, 2342282, 2343844, 2344862, 2345939, 2374886, 2384620, 2398703, 2414135, 2419493, 2421904, 2431254, 2452258, 2470507, 2320781, 2320781, 2320781, 2337810, 2345946, 2356142, 2356142, 2356155, 2374303, 2378382, 2381628, 2388393, 2395787, 2403721, 2406900, 2431262, 2439060, 2442487, 2332977, 2341611, 2341613, 2343332, 2343332, 2344271, 2346316, 2350291, 2350291, 2357379, 2361010, 2367418, 2367418, 2367426, 2370634, 2374371, 2404509, 2423600, 2424387, 2426405, 2491198, 2504866, 2320794, 2320794, 2320794, 2332984, 2349179, 2352519, 2352530, 2374377, 2377619, 2377620, 2380655, 2380656, 2380656, 2380656, 2383410, 2383410, 2390934, 2417553, 2433540, 2437127, 2453492, 2341639, 2344273, 2344274, 2344274, 2345961, 2355663, 2357626, 2367445, 2369446, 2378396, 2342292, 2342292, 2345963, 2350422, 2357629, 2330839, 2345965, 2353077, 2353077, 2353078, 2353078, 2353078, 2361032, 2361032, and 2481362 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Metasul® Durom® Femoral component Sterile, Rx REF Numbers: 01.00211.140, 01.00211.144, 01.00211.152, 01.00211.154. 01.00211.156, 01.00211.158, and 01.00211.160. Lot: 2367454, 2367454, 2367454, 2367454, 2367455, 2367455, 2374382, 2374382, 2374382, 2374382, 2381632, 2381632, 2381634, 2381634, 2409055, 2414048, 2397713, 2397713, 2417888, 2380622, 2380622, 2388389, 2388389, 2388389, 2453506, 2422704, 2375235, 2375235, 2375235, 2394700, and 2508571 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Stem REF Numbers: 01.00351.005, 01.00351.006, lots 2330077, 2397912 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Distal centralizer, cemented, sterile, Rx REF Numbers: 01.00351.005, 01.00351.006, 01.00351.014, 01.00351.214, 01.00351.216, 01.00351.416, 01.00351.620, 01.00356.008, 01.00356.010.Lot 2330077, 2397912, 2319413, 2280640, 2386348, 2399448, 2389980, 2389980, 2389980, 2389980, 2426020, and 2430035. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30® Proximal positioner REF Number: 01.00351.265, lot 237973 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Fitmore" Hip Stem REF Numbers: 01.00551.102, 01.00551.103, 01.00551.104, 01.00551.106, 01.00551.108, 01.00551.109, 01.00551.110, 01.00551.111, 01.00551.112, 01.00551.201, 01.00551.202, 01.00551.203, 01.00551.204, 01.00551.205, 01.00551.206, 01.00551.207, 01.00551.208, 01.00551.209, 01.00551.210, 01.00551.211, 01.00551.301, 01.00551.302, 01.00551.303, 01.00551.307, 01.00551.308, 01.00551.309, 01.00551.312, 01.00551.313, 00551.402, 00551.405, 00551.407, 00551.408, 00551.409, and 00551.411. Lot: 2492112, 2405383, 2461916, 2486221, 2486734, 2414003, 2379860, 2384352, 2382041, 2406708, 2486291, 2458770, 2479902, 2508062, 2381041, 2486227, 2384141, 2463958, 2476244, 2375830, 2455461, 2470164, 2493934, 2496756, 2376419, 2494086, 2496005, 2528591, 2376542, 2478039, 2500720, 2507124, 2376544, 2461922, 2495240, 2376606, 2384344, 2478043, 2476248, 2478878, 2479894, 2490109, 2489434, 2493749, 2389960, 2478868, 2476256, 2478035, 2397744, 2493741, 2516631, 2398158, 2478724, 2411541, 2407956, 2401609, 2401590, 2402542, 2402544, 2401623, and 2405399 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Wagner cone Prosthesis, uncemented, sterile, Rx REF Numbers: 01.00561.214, 01.00561.215, 01.00561.222, 01.00561.313, 01.00561.314, 01.00561.316, 01.00561.317, 01.00561.318, 01.00561.319, and 01.00561.321 Lot:2323157, 2411401, 2505266, 2352457, 2352457, 2323311, 2381296, 2446509, 2336139, 2451855, 2397244, 2451874, 2459988, 2517770, 2528611, 2455390, 2336084, 2413210 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices CoCr Head, sterile, Rx REF Numbers: 01.01012.384, 01.01012.385, 01.01012.386, 01.01012.387, and 01.01012.388 Lot2369409, 2435773, 2448280, 2480485, 2480485, 2397348, , 2402739, 2412633, , 2420719, 2481695, 2520521, 2333576, 2354292, 2369416, 2398778, 2412631, 2447614, 2462604, 2484118, 2498778, 2501857, 2524940, 2524941, 2527698, 2531506, 2531507, 2330195, 2341655, 2448278, 2482086, 2512070, 2518101, 2490816, and 2498784 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Humeral stem REF Numbers: 01.04201.072, 01.04201.092, 01.04201.102, 01.04201.122, 01.04201.142, 01.04211.072, 01.04211.092, 01.04211.122, and 01.04211.142 Lot 2333904, 2403849, 2416919, 2443150, 2327341, 2452413, 2320506, 2323574, 2364979, 2373235, 2406171, 2416913, 2438286, 2485091, 2331445, 2357957, 2436420, 2440113, 2470299, 2492996, 2320516, 2334543, 2387483, 2411827, 2421859, 2441600, 2511328, . Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Fracture Humeral stem REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Humeral Head REF Numbers: 01.04212.400, 01.04212.420, 01.04212.440, 01.04212.460, 01.04212.480, 01.04212.500, 01.04213.480, and 01.04213.520. LotsLots: 2335921, 2388114, 2475819, 2475819, , 2444895, 2485536, 2397602, 2437195, 2485540, 2397014, 2408970, 2483098, 2370444, 2437201, 2458785, 2458785, 2323268, 2434637, 2334433, 2473843, 2530732, 2336444 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices zimmer Anatomical Shoulder Glenoid S, cemented, sterile; REF 01.04214.340 PE Keeled Glenoid S, cemented, sterile; REF 01.04214.345, Glenoid M, cemented, sterile; REF 01.04214.370, Glenoid L, cemented, sterile; REF 01.04214.400 PE Keeled Glenoid L, cemented, sterile; REF 01.04214.405 REF Numbers: 01.04214.340, 01.04214.345, 01.04214.370, 01.04214.400, and 01.04214.405. Lot 2416527, 2430357, 2447460, 2450204, 2348311, 2348311, 2364768, 2364768, 2364768, 2403597, 2418592, 2418592, 2452946, 2453947, 2503319, 2503319, 2517200, 2329832, 2349655, 2388161, 2453280, 2453280, and 2533474. Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Revision Humeral stem,7,9,12,14 and Anatomical Shoulder Fracture Humeral stem REF Numbers: 01.04215.072, 01.04215.092, 01.04215.122, 01.04215.142. , 01.04217.072, 01.04217.132 Lot 2398402, 2485014, 2347028, 2347028, 2380422, 2348099, 2341901, 2435527, 2398475 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Zimmer Inverse/Reverse Screw system, REF Numbers: . 01.04223.018, 01.04223.024, 027, 030, 033, 036, 042 Lot 2398030, 2430525, 2384923, 2390913, 2396961, 2399397, 2416652, 2424581, 2430509, 2449770, 2497224, 2383780, 2430522, 2430523, 2430523, 2477654, 2484611, 2383751, 2396967, 2399398, 2416653, 2416653, 2422337, 2429084, 2447019, 2463617, 2521820, 2349258, 2383781, 2388857, 2420337, 2428101, 2447022, 2521822, 2383794, 2385133, 2387452, 2390941 , Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse Humeral Cup REF Numbers: 01.04223.100, 01.04223.106, 01.04223.111, 01.04223.121, 01.04223.190, and 01.04223.196.Lot 2310656, 2429295, 2468509, 2310648, 2410046, 2486362, 2474203, 2317777 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse/Reverse Glenoid Sterile, Rx REF Numbers: 01.04223.200 and 01.04223.236 2313338, 2314443, 2318819, 2331464, 2342906, 2343151, 2346399, 2368714, 2387755, 2425692, 2468583, 2468587, 2471765, 2503386, 2516402 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx REF Numbers: 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406 Lot:2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, 2309008, 2309008, 2446964, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Ball taper for humeral stem REF Numbers: 01.04227.102, Lot:2350372, 2381792, 2398201, 2452078, 2460783 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Anatomical Shoulder" Fracture Humeral Head REF Numbers: 01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485 Lot 2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, 2441471 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices CLS Stem REF Numbers: 29.00.09.137, 29.00.09.162, 29.00.39.070, and 29.00.39.125 Lot 2397894, 2393484, 2480480, 2439729, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Original M.E. Mueller" Low Profile Cup Sterile, Rx REF Numbers: 63.32.46, 63.32.60 and 63.32.62.Lot 2378026, 2468907, 2370934 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Set screw M6 REF Numbers: 01.03710.006 and 01.03711.006 Lot 2381797, 2429082 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Universal spacer 6-45 REF Number: 01.03710.645, Lot 2323776, 2340853, 2347195, 2347196, 2349405, 2352968, 2361598, 2363757, 2368549, 2371803, 2374584, 2374695, 2390243, 2390244, 2392322, 2394946, 2395677, 2410170, 2410171, 2413068, 2414198, 2417869, 2419315, 2419317, 2424170, 2430156, 2439598, 2449297, 2452033, 2454477, 2455648, 2455649, 2469131, 2469132, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® L.I.S. Stabilizing cord Rx, Sterile REF Numbers: 01.03711.100 and 01.03711.200 Lot2290106, 2322753, 2322757, 2325303, 2328500, 2350135, 2363929, 2363972, 2366663, 2377045, 2391793, 2409738, 2422397, 2444114, 2448948, 2453742 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Revision + set screw REF Numbers: 01.03716.035, 01.03716.040, 01.03716.045, 01.03716.050, 01.03716.435, 01.03716.440, 01.03716.445, 01.03716.450, 01.03716.455 and 01.03717.250 Lot: 2368864, 2344115, 2367073, 2396142, 2334238, 2444021, 2377110, 2305486, 2377111, 2323497, 2389720, 2403550, 2433036, 2444022, 2298967, 2305536, 2348795, 2358159, 2368866, 2368867, 2389721, 2394352, 2449099, 2368870, 2441343, 2367060, 2367062, 2373095, 2373097 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® HA Pedicle + set screw REF Numbers: 01.03756.040, 01.03756.050, 01.03756.440, 01.03756.445, 01.03756.450, 01.03756.455, 01.03757.235, 01.03757.240, 01.03757.245, 01.03757.250, 01.03757.255, 01.03758.040, 01.03758.050 and 01.03758.055 Lot: 2399360, 2502246, 2519160, 2323382, 2399361, 2459377, 2500751, 2383797, 2425044, 2449147, 2373116, 2411907, 2323399, 2344133, 2344133, 2426558, 2359295, 2426560, 2456268, 2502250, 2323446, 2488882, 2444047, 2323449, 2433071, 2323450, . Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthru, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices DTO" Implant REF Numbers: 01.03791.050, 01.03791.060, and 01.03791.080 Lot: 2417930, 2417948, 2417950, 2417956, 2429074, 2432771, 2462074, 2512965, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Dynesys® Top-Loading System Cannulated Pedicle + Set Screw REF Numbers: 01.03915.245, 01.03916.055, 01.03916.435, 01.03916.440, 01.03916.445, 01.03916.450, 01.03916.455, 01.03917.235, 01.03917.245, 01.03917.250, 01.03917.255, 01.03918.040, 01.03918.045, 01.03918.055, 01.03955.235, 01.03955.245, 01.03955.255, 01.03956.035, 01.03956.435, 01.03956.440, 01.03956.450, 01.03957.240, 01.03957.250, 01.03957.255, 01.03958.045 and 01.03958.050. Lot:2443724, 2443727, 2443738, 2443740, 2443750, 2443751, 2443770, 2449369, 2449373, 2449374, 2449375, 2449416, 2459041, 2459046, 2459051, 2459087, 2459106, 2471700, 2475668, 2475670, 2475672, 2475681, 2475690, 2475694, 2475695, 2475702, 2475704, 2528982, 2528984, 2528987, 2528988, 2529021, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB® cancellous screw REF Number: 02.02152. 085 Lot 2477869 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB® screw Ų 4.0 self-tapping REF Numbers: 02.02155.026 and 02.02155.030 Lots2450611, 2475382 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB®-PT lateral proximal 3 hole tibial plate REF Numbers: 02.02261.305, 02.02261.307, 02.02261.309, and 02.02261.313. Lot:2442904, 2341498, , 2402100, 2407066, 2414036, 2422428, 2426611, 2434987, 2442908, 2387467, 2387467, 2402996, 2407064, 2422433, 2450659, 2450659, 2450644, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices NCB®-PH Plate REF Numbers: 02.02262.105 and 02.02262.107. Lot 2450659, 2450644 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Sirus® intramedullary nail for tibia, cannulated Ų REF Numbers: 02.02631.030, 02.02631.031, 02.02631.033, 02.02631.034, 02.02631.036, 02.02631.038, 02.02631.130, 02.02631.131, 02.02631.133, 02.02631.134, 02.02631.142, 02.02631.233, 02.02631.925, 02.02631.928, 02.02631.930, 02.02631.931, 02.02631.933, 02.02631.934, 02.02631.936, and 02.02631.940. Lot: 2394172, 2400103, 2400105, 2403109, 2403116, 2403125, 2403127, 2403136, 2403138, 2406268, 2406270, 2406272, 2406276, 2406278, 2406280, 2408059, 2408125, 2408131, 2408135, 2409963, 2409973, 2412348, 2414763, 2414765, 2414767, 2414773, 2414775, 2428019, 2429497, 2449749, 2449758, 2455924, 2477033, 2477059, 2490726, 2498026, Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices Kopf Adapter S Sterile, Rx REF Numbers: 01.00185.145, 146, 147, 148 2329720, 2345868, 2351558, 2351558, 2357964, 2357985, 2363710, 2365318, 2390727, 2401986, 2404475, 2420196, 2424824, 2424824, 2428509, 2449961, 2469199, 2476706, 2476706, 2476708, 2476708, 2486173, 2324764, 2335268, 2339607, 2342207, 2342207, 2342209, 2342211, 2354632, 2357988, 2365331, 2368841, 2385720, 2388044, 2396086, 2399440, 2404481, 2408183, 2414476, 2414480, 2420203, 2420203, 2424841, 2428528, 2430914, 2433313, 2455294, 2462031, 2462048, 2469203, 2469203, 2476713, 2476718, 2486178, 2486178, 2486180, 2499005, 2499005, 2509186, 2516387, 2516387, 2516389, 2314373, 2322686, 2329747, 2339609, 2339611, 2342218, 2350072, 2351571, 2351573, 2354637, 2356264, 2360204, 2430920, 2443367, 2455300, 2476723, 2482727, 2322688, 2322689, 2322689, 2335264, 2335264, 2336972, 2336972, 2399446, 2428549, 2428549, 2428549 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices MS-30 Shaft, Sterile, Rx 30.00.49-100, 140, 160; Lots 2396807, 2390863, 2321477 Class II Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the information on the patient label (in rare cases) may be wrong. Zimmer, Inc.
Devices STA Satellite Automated Multi-Parameter Analyzer This system is a fully automatic clinical instrument indicated and intended for the performance of tests on human plasma, the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. K082248 D089976 Ref 58104 units Class II Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite®. Diagnostica Stago, Inc.
Devices Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone. K113327 Catalog No: Telescopic Strut Extra Short Hoffman LRF Length: 4933-0-100 :100-125mm (Black) 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); Lot Code: 4933-0-100 Telescopic Strut Extra Short Hoffman LRF Length 100-125mm (Black) X28937; Z04197; Z09163; Z09597; Z12135; 4933-0-120 Telescopic Strut Short Hoffman LRF Length: 119-161 mm (Yellow) X28961; Z04199; Z09161; Z09769; Z12012; 4933-0-140 Telescopic Strut Medium Hoffman LRF Length 138-201 mm (Blue) X34352; Z04200; Z05068; Z09011; Z09598; Z10872; 4933-0-180 Telescopic Strut Long Hoffman LRF Length: 177-277 mm (Red); X28963 ;Z04429; Z09471; Z11686 Class II Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS. Stryker Howmedica Osteonics Corp.
Devices The brand name of the device is AlgiNot, a dental impression material. Product Part Numbers AlgiNot Intra Kit 34683 AlgiNot Volume Refills 34682 Lot Number 1-1017 AlgiNot is a Class II Medical Device. The device listing number this product is 0136496 and the establishment registration number for Kerr Corporation is 1815757. Intended as an alternative to traditional alginate materials. ’Product Part Numbers Lot Number AlgiNot Intra Kit 34683 1-1017 AlgiNot Volume Refills 34682 1-1017 Class II The firm recalled the product because it may cure harder than expected within the shelf life, which could result in a material that may be more difficult to remove. Use of this product on patients with loose teeth may result in possible tooth fracture or tooth extraction. Kerr Corporation
Devices Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 1 (List Number 06F12-09; Lot Number 071039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 2 (List Number 06F12-10; Lot Number 081039) Cliniqa Liquid QCTM Cardiac Marker Control for i-STAT Level 3 (List Number 06F12-11; Lot Number 091039) Usage: Assayed human plasma which may be used to verify the integrity of newly received i-STAT CK-MB cartridges. Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 2 (List #06F12-10; Lot Number 081039) Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 3 (List #06F12-11; Lot Number 091039) Class III Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 081039); and i-STAT Level 3 (List #06F12-11; Lot Number 091039) results may be generated below the lower value assignment range for some vials. Abbott Point Of Care Inc.
Devices ABL80 FLEX CO-OX analyzer, model #393-841 (all software versions prior to 1.35). The ABL80 FLEX CO-OX is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL80 FLEX CO-OX system is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point of care setting Serial Numbers: all ABL80 FLEX CO-OX analyzers with sofware versions 1.30, 1.31, 1.32, 1.33, and 1.34. Class II The recall was initiated because SenDx Medical Inc. became aware of a software issue in the ABL80 FLEX CO-OX analyzer related to the reporting of the hemoglobin fractional parameters. Sendx Medical Inc
Devices Sunquest Laboratory, version 7.0 not available not available Class II Sunquest is recalling Sunquest Laboratory version 7.0 because when saving an Accession to a non-current Episode/Event, a User-Defined field can be incorrectly replaced by the current Episode/Event User-Defined data. Sunquest Information Systems, Inc.
Devices Sunquest Application Interfacing Outbound Phlebotomy Point of Care Interface, v3.0.0_07222004 and later. v3.0.0_07222004 and later Class II The recall was initiated because Sunquest Information System has confirmed reports of an Outbound Phlebotomy Point of Care (POC) interface is combining patient orders inappropriately. Sunquest Information Systems, Inc.
Devices S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 10E06219,10E06220, 10E06231-10E06234, 10E06239-10E06241, 10E06255-10E06273, 10E06286-10E06289, 10E06291-10E06355, 10E06359-10E06364, 10E06366, 10E06368-10E06383, 10E06385, 10E06387-10E06391,10E06395-10E06401, 10E06403-10E06447, 10E6502. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 10E51854,10E51856-10E51858, 10E51860, 10E51861, 10E51864, 10E51867, 10E51870, 10E51871, 10E51873, 10E51880-10E51897, 10E51899-10E51913. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 50E50766--50E50769, 50E50772-50E50774, 50E50783-50E50784. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 50E00680--50E00681, 50E00688, 50E00696-50E00706, 50E00708-50E00718. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. Serial Numbers: 58E00135; 58E00136 Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specification electrical component was determined to be the cause of some of these events. Sorin Group USA, Inc.
Devices Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. Part number: 01-1500-9014 and Lot #'s 1466707 and 1466710 Class II A complaint received from sales representative that a replenishment instrument was too short. Upon investigation, it has been determined that the device was not manufactured to design specifications and will not function as intended. OrthoPediatrics Corp
Devices Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. Part Numbers 601-0007 and 601-0010, all lots Class II The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130°C. The correct sterilization temperature should be listed as 132°C and/or 270°F. Ormco/Sybronendo
Devices Pinnacle3 VCC P/N 4598 001 41341 REV A, Philips Medical Systems (Cleveland), Inc., Fitchburg, WI. Pinnacle3 Radiation Therapy Planning System is a computer software package intended to provide support for radiation therapy treatment planning for the treatment of benign or malignant disease processes. Pinnacle3 Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. The device is indicated for use in patients deemed to be acceptable candidates for radiation treatment in the judgment of the clinician responsible for patient care. Plans generated using this system are used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel. Serial # 317, 318, 319, 320,321,342, 343, 344,345, 346, 347 Class II Philips Medical Systems Cleveland), Inc. is recalling Pinnacle3 Virtual Client Connection software version 3.1 due to an improper release and subsequent distribution. Philips Medical Systems (Cleveland), Inc.
Devices The touchscreen display (model 94267) designed for use with the XPREZZON bedside monitor (model 91393) is width-452 mm (17.2 inches) and height- 368 mm (14.5 inches). The depth without the pedestal --- 67.7 mm (2.67 inches). The display is an integrated LCD 19-Inch. The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules. Serial Number for U.S. Cosignees: PRO-12240004, PRO-12240015, PRO-12240017, PRO-12240018, PRO-12240022, PRO-12240026, PRO-12240028, PRO-12240030, PRO-12240031, PRO-12240032, PRO-12240033, PRO-12240034, PRO-12240036, PRO-12240037, PRO-12240038, PRO-12240040, PRO-12240041, PRO-12240058, PRO-12240059, PRO-12240062, PRO-12240063, PRO-12240077, PRO-12240084, PRO-12240090, pro-12260008, PRO-12260016, pro-12260018, PRO-12260023, pro-12260024, PRO-12260032, pro-12260033, pro-12260035, PRO-12260036, PRO-12260037, pro-12260038, pro-12260041, pro-12260044, pro-12260055, pro-12260059, PRO-12260060, PRO-12260062, pro-12260064, pro-12260065, pro-12260068, pro-12260070, pro-12260071, pro-12260073, PRO-12260076, PRO-12260077, PRO-12260080, PRO-12260081, PRO-12260082, PRO-12260083, PRO-12260085, PRO-12260086, PRO-12260087, PRO-12260088, PRO-12260092, PRO-12260094, PRO-12260096, PRO-12260097, pro-12260121, pro-12260125, pro-12260131, pro-12260164, pro-12260167, pro-12260172, PRO-12260175, PRO-12260183, pro-12260185, pro-12280036, pro-12280049, pro-12280062, pro-12280119, pro-12280121, pro-12280126, pro-12280127, pro-12280131, pro-12280133, pro-12280134, pro-12280136, pro-12280137, pro-12280152, pro-12280155, pro-12280156, pro-12280160, pro-12280161, pro-12280162, pro-12280163, pro-12280173, pro-12280174, pro-12280175, pro-12280177, pro-12280182, pro-12280205, pro-12280232, pro-12280272, pro-12280273. Serial number for International Consignees: PRO-12240056, PRO-12260005, pro-12260006, PRO-12260012, PRO-12260013, pro-12260019, PRO-12260020, PRO-12260021, pro-12260022, pro-12260025, pro-12260026, pro-12260027, pro-12260028, PRO-12260029, PRO-12260030, pro-12260031, PRO-12260040, PRO-12260043, PRO-12260045, PRO-12260046, pro-12260047, PRO-12260051, PRO-12260053, PRO-12260057, PRO-12260075, pro-12260079, PRO-12260111, PRO-12260118, PRO-12260122, pro-12260124, pro-12260128, pro-12260140, pro-12260143, PRO-12260146, PRO-12260147, PRO-12260149, PRO-12260151, PRO-12260152, PRO-12260153, PRO-12260155, PRO-12260156, PRO-12260157, pro-12260158, PRO-12260159, PRO-12260160, PRO-12260161, PRO-12260162, PRO-12260163, PRO-12260169, PRO-12260170, pro-12260171, pro-12260174, PRO-12260176, PRO-12260178, pro-12260179, pro-12260180, pro-12260182, pro-12260189, pro-12260190, pro-12260191, PRO-12260192, pro-12260193, pro-12260195, pro-12260199, pro-12280006, pro-12280023, pro-12280132, pro-12280135, pro-12280141, pro-12280206, pro-12280225. Class II Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. Spacelabs Healthcare, Llc
Devices AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS AdVance" Male Sling System (Intl) 72404224 AMS Male TO Sling System (Intl). The AMS AdVance Male Sling System is intended for the placement of a suburethral sling for the treatment of male stress urinary incontinence (SUI). Part # Lot/Serial Range 720088-01 722022001 to 796127002 720088-02 722024001 to 790266012 72404224 742528001 to 795689010 Class II American Medical Systems® (AMS) is issuing a voluntary recall on a number of lots of the AdVance® Male Sling System (AdVance). AMS has recently received a small number of complaints regarding the resorbable suture in the AdVance sling not lasting for the entire 15 month shelf life of the product. An internal investigation has been conducted and confirmed that some sutures degraded prior to the expiration of the labeled shelf life. At this time AMS cannot confirm that there is no potential for premature degradation of the bioabsorbable tensioning sutures on the product included in this recall. American Medical Systems, Inc.
Devices ULTRA Fabric Reinforced surgical Gown X-Large Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Product Code 95221 - All lot numbers beginning with: AH9284*** to AH9356***, AH0007*** to AH0356***, AH1008 *** to AH1364***, AH2006*** to AH2146*** Class II Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Kimberly-Clark Corporation
Devices MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175*** Class II Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. Kimberly-Clark Corporation
Devices TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine. It intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the Zodiac Polyaxial Pedicle Screw System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. Lot # 634745 Class II The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw Assembly was laser marked with the incorrect length of 45 MM. Alphatec Spine, Inc

Mindray DS USA, Inc. Has Initiated a Recall Affecting the A3/A5 Anesthesia Delivery System

Mindray Medical International Limited (NYSE: MR), has initiated a recall affecting the A3/A5 Anesthesia Delivery System.  Mindray has initiated this recall due to the possibility of a system leak resulting from improper seating of the CO2 absorbent canister gasket.

Customers who have a system(s) subject to this recall were notified by on August 8, 2012 by letter via US Postal Mail, return receipt required. 

Units with the affected canister gaskets were shipped between May 31, 2011 and July 15, 2012 in the United States, Latin America and Australia.

Consumers who have questions should call:

Mindray North America at 1-800-288-2121 ext. 5050, Monday-Friday, 8:30-5:30, EST

WEEK ENDING NOVEMBER 10

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Medpro Elastomeric Infusion Pump. AccuFlux, Model # CT-0020-100H. Product Usage: The devices are intended for patients requiring intravenous, percutaneous, subcutaneous, intra-operative sites or epidural administration of medications. It is the responsibility of the user to ensure that the medication is prepared and administered accordance with the drug manufacturers package insert. The devices deliver controlled amounts of medication directly to the intraoperative site for pain management and or antibiotic administration. The devices infuse the medication at an hourly flow rate. Medications are infused intraoperatively and postoperatively through intramuscular or subcutaneous routes. The devices are also intended for controlled delivery of local anesthetics in close proximity to nerves for post operative regional anesthesia and pain management. Routes of administration may be intraoperative or percutaneous. It is for continuous infusion of medications for general infusion use, including antibiotic delivery and chemotherapy. AccuFlux, Lot#: 91209. Class II The recall was initiated because First Medical Source has confirmed that these lots may have a higher flow rate than specified. The use of this product may lead to over-administration of drug solutions to the patients. The product may fail to meet nominal flow rate of ±15%. First Medical Source LLC
Devices Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. Lot 1104-01 Class II The tip of the product could come loose or unravel. Progressive Medical Inc
Devices QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates the blood, eliminates carbon dioxide and regulates blood temperature. The devices utilization period is limited to six hours. All sizes and membrane types of QUADROX-i oxygenators, i.e., QUADROX-i(D) Adult, Small Adult, Pediatric and Neonatal with SOFTLINE and BIOLINE Coating; Catalogue numbers to include BE-HMOD XXXXX; BEQ-HMO XXXXX; BEQ-HMOD XXXX; BEQ-HMOD XXXXX; BO-VKMO XXXXXX; HMO XXXX; HMO XXXXX; HMOD XXXX; HMOD XXXXX; VKMO XXXX; VKMO XXXXX; X HMO XXXXX U; XHMOD 30000 U; X VKMO XXXXX U; and X 1895. QUADROX-iR with SOFTLINE and BIOLINE Coating - Catalogue numbers to include XVIVO HMO 70100 U. HLS module 5.0 and 7.0 in HLS Sets: Catalogue numbers to include BEQ-HLS 5050 and BEQ-HLS 7050. HLS module 5.0 and 7.0 in HIT HLS Sets: Catalogue numbers to include BO-HLS 5050 and BO-HLS 7050. Custom Tubing Packs containing oxygenators listed above: Catalogue numbers to include TOP XXXXX; TOP XXXXXns; TOP XXXX; BO-TOP XXXXX; BEQ TOP XXXXX; BSQ-TOP XXXX; and BSQ-TOP XXXXX. Note: an X was used to represent variations of catalogue numbers. Class II It has come to firm's attention that, in some rare cases, the blood outlet connector on some models of MAQUET Oxygenators may detach from the oxygenator. This event has occurred in about 0.01% (1:10,000) of units shipped. Maquet Cardiovascular Us Sales, Llc
Devices "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone. Lot # 330889 and Catalog: PFT-00M - No Expiration date Class II ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle. Linvatec Corp. dba ConMed Linvatec
Devices Software for Vitrea, Vitrea fX, and Vitrea Enterprise Suite (VES): VPMC-09293C Vitrea . Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. The software is a medical diagnostic system that allows the processing, review, analysis, communication, and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. It provides the ability to review digital images from original DICOM data for multiple modalities, including CT, MR, DR, CR, XA, US, NM, PET, etc. The software is not meant for primary image interpretation in mammography. The Vitrea VScore option is intended for cardiac scoring from whole body CT derived measurements, including non-invasive detection and quantification of atherosclerotic plaque. Two image processing options, EKG Gate and Auto Gate, allow the operator to select images with reduced motion artifacts when processing data for Coronary Artery Calcification Scoring. Model Number Vitrea 5.2, 6.0, 6.1, and 6.2 VPMC-09346B Vitrea fX Model Number Vitrea fX 3.1, 5.2, 6.0, 6.1, and 6.2 VPMC-11731A Vitrea Enterprise Suite Model Number Vitrea Enterprise Suite 1.3, 6.0, 6.1, and 6.2. Class II Vital Images has found two potential errors in calcium score values in restored snapshots of studies generated through use of Vitrea or Vitrea Enterprise Suite. This issue affects Version 3.1 of Vitrea fX; Version 5.2 of Vitrea; Versions 6.0, 6.1 and 6.2 of Vitrea and Vitrea fX; and Versions 1.3, 6.0, 6.1 and 6.2 of Vitrea Enterprise Suite; and all updates to those versions. Vital Images, Inc.
Devices Myocardial Heart Wires Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator. Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174 Class II Oscor, Inc. in Palm Harbor, FL is recalling myocardial heart wires, models TME60S, TME64S, TME64C, TME64S-3, TME65S, and TME66S. The recall was initiated due to the spacing between anchoring zig-zag to electrode is out of specification. Oscor, Inc.
Devices HeartSine Samaritan(R) 300/300P PAD devices with serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Product Usage: Samaritan 300/300P PAD is indicated for use on victims of sudden cardiac arrest who are exhibiting the following signs: Unconsciousness Not breathing Without circulation Serial numbers 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C00210106 Class I Certain Samaritan 300/300P PAD devices may experience one or both of the following conditions that could affect the ability to deliver therapy to a patient in an SCA event if needed: Issue 1 (On/Off Issue): the device may turn itself on and off without input from the user. When this occurs, the normal sequence of audible instruction prompts that occurs when the device is turned on will be emitted from the device. If the device does not detect that the audible prompts are followed (e.g., a patient is connected to the electrodes to allow the device to read the patient's ECG and start the normal sequence of events), the device will automatically switch off after 10 minutes to save power. this sequence of on-off events can happen repeatedly or intermittently. If this condition is undetected, the battery will eventually become completely depleted. In worst-case situations, it is possible that the battery could be depleted below the minimum battery capacity to allow for the delivery of therapy within a week. However, a device experiencing this issue will be capable of delivering therapy provided that an adequate power source is available. Devices potentially subject to this issue were manufactured between August 2004 and December 2010 and have a warranted life of up to 7 years. Issue 2 (Battery Management Software Issue): Certain Samaritan 300/300P PAD devices containing early versions of the battery management software may misinterpret a temporary drop in battery voltage as signaling a low battery. This issue will result in the device prematurely displaying the low battery warning and turning itself off even though sufficient battery capacity remains. This may occur when the device performs its weekly self-test, or when the device is turned on, or when the device is preparing to deliver a shock, or after delivering a shock. If the low battery warning is triggered due to this issue, the device will have sufficient power to deliver multiple shocks, but it is possible that the device may not deliver any shocks, or it may only deliver one shock before turning itself off. If this occurs, delivery of any subsequent shocks may be delayed and would likely only be delivered at the lowest energy level of 150 Joules. Once the device has experienced this condition, it is more likely to experience it again. This condition can occur when the installed PAD-PAk is an 800mAh capacity battery. This software version was distributed until the end of December 2010. Devices containing software version 1.4.2/3.2.0 or higher are not susceptible to this issue. Heartsine Technologies, Limited
Devices Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216(10334837)(250 Tests) Not CE Marked; OUS: REF03204829(10310271)(50 Tests); REF 01157807(1 0314722) (250 Tests) CE Marked; REF 09010686 (10340081)(250 Tests). The ADVIA Centaur BR assay is an in vitro diagnostic test for the quantitative serial determination of cancer antigen CA 27.29 in human serum using the ADVIA Centaur and ADVIA Centaur XP systems. The test is intended for use as an aid in monitoring patients previously treated for Stage II or Stage Ill breast cancer. Serial testing for CA 27.29 in the serum of patients who are clinically free of disease should be used in conjunction with other clinical methods used for the early detection of cancer recurrence. The test is also intended for use as an aid in the management of breast cancer patients with metastatic disease by monitoring the progression or regression of disease in response to treatment. BR Assay for CA 27.29 BR Assay Kit Lots ReadyPack® Lot Number Ending in 198:. 89291198,86469198,85752198,88939198, 87757198, 85459198, 88319198, 86295198, 85194198 ReadyPack® Lot Number Ending in 202: 93573202, 91045202, 93664202, 90880202, 93157202,91126202,90494202. BR Assay for CA 15-3 ReadyPack BR Assay Kit Lots Lot Number Ending in 199: 87425199,85862199,86949199,85945199 Class II BR Assay for CA 27.29 Calibration Interval Change due quality control (QC) results outside of the expected ranges. Siemens Healthcare Diagnostics, Inc
Devices Aviator Drill Bit (10 mm, 12 mm, 14 mm, 16 mm, Manufactured by: Stryker Spine SAS Z.1 Marticot -33610- Cestas France +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by Stryker Spine 2 Pearl Ct., Allendale NJ 07401-1677 USA +1-201-750-8000 Drill bits are reusable instruments, sterilized prior to use, used in conjunction with an Aviator Drill Guide to provide a pathway for screw insertion. The aviator Anterior Cervical Plating (ACP) System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. E207315 Catalog number 48770610, 48770612, 48770616 All lots Class II Aviator drill bits are 10 mm longer than the Reflex Hybrid drill bits and are not interchangeable which could lead to over-drilling by as much as 10 mm. Stryker Spine
Devices MOSAIQ MOSAIQ is an image-enabled electronic medical record system (EMR) used for oncology workflow management. It lets users supply electronic patient charts and assemble care plans, order diagnostic tests, and prescribe medications. It also lets users import, view, annotate, manipulate, enhance, manage, and archive images. Version 2.00 to 2.41 Class II A patient was seriously mistreated after a user made and saved an inadvertent change to the definition of a treatment filed in MOSAIQ. Elekta, Inc.
Devices Hip Components: INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V08215433, X01383177, X02394358, X06418357, X07439692, and X08428844 PROFEMUR(R) NECK 8DG A/R LONG, PHA01234, Lot Numbers: X01383179, X02388478, X02396411, X03396412, X04401235, X04401236, X06418358, X06418359, and X07420162 PROFEMUR(R) NECK 15DG A/R SHORT, PHA01242, Lot Numbers: U0366352, V07215735, W12383180, X01388480, X0193876A, X04401237, X04418360, and X06420163 PROFEMUR(R) NECK 15DG A/R LONG, PHA01244, Lot Numbers: U0366343, X01383182, X02388481, X02396414, X03401238, X04410875, X05418362, X06418361, and X07420164 PROFEMUR(R) NECK 8DG VAR/VAL SHORT, PHA01252, Lot Numbers: W11385750, X05418363, and X07418365 PROFEMUR(R) NECK 8DG VAR/VAL LONG, PHA01254, Lot Numbers: V06185863, X01383187, X01385844, X01388485, X04401243, X04401244, X05418366, X06418367, and X07420167 COTYLE "EHS-E" S/CIMENT S/REVET. T.56*41 18 DEG G2, PHA01956, Lot Number: X04396684 INSERT CERAMIQUE 18° 28/37G T 28 GROUPE 1 BIOLOX FORTE, PHA02046, Lot Numbers: X02400415, X04427560, X05429759, X07429026, and X10459182 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02052, Lot Numbers: X01383643, X02388588, X02396690, X03401463, X04416678, X05420309, and X05427559 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02058, Lot Numbers: X03416959, X04428692, X06429028, and X09440377 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 1, PHA02246, Lot Numbers: X01383000, X02383646, X03388589, X04396691, and X07420310 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 2, PHA02252, Lot Numbers: X02383647, I X02388433, X03388590, X04396692, X05401465, X07418475, and X07420311 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 3, PHA02258, Lot Numbers: X02388434, X05401466, and X07429040 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 4, PHA02264, Lot Numbers: U0366160, V11289411, and V12289425 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 2, PHA02352, Lot Numbers: X05401467 and X07418477 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 3, PHA02358, Lot Number: X02383648 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G1, PHA02546, Lot Number: X06418478 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G2, PHA02552, Lot Numbers: W01272753, W01289415, W04314279, W12376869, X04396693, X08418479, and X08420314 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G3, PHA02558, Lot Numbers: U0668153, W12378518, X01383651, X03388595, X04396694, and X07418481 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G2, PHA02652, Lot Numbers: X04388596, X04396695, and X05401471 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G3, PHA02658, Lot Numbers: X03396357, X05418482, and X07428694 INSERT CERAMIQUE 18° 32/41G T 32 GROUPE 2 BIOLOX FORTE, PHA02852, Lot Numbers: X02388598, X02411905, X03401590, PHA02852, X03411906, X05429029, and X06435536 INSERT CERAMIQUE 18° 32/48G T 32 GROUPE 3 BIOLOX FORTE, PHA02858, Lot Numbers: W12389006, W12395616, X0138859, X0139592, X02396697,X03401591, X03411904, and X05418484 INSERT CERAMIQUE 18° 32/52G T 32 GROUPE 4 BIOLOX FORTE, PHA02864, Lot Numbers: X01400420, X01402627, X04428395, and X09473192 SHELL SCREW D=5.5 L=15 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02915, Lot Numbers: X02388607, X02396698, X04401592, X04410964, X06428695, andX06429049 SHELL SCREW D=5.5 L=20 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02920, Lot Numbers: X03401593, X04410965, and X06429050 SHELL SCREW D=5.5 L=25 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02925, Lot Numbers: U0370883, U1085036, W04314684, X01383654, X02388609, X03396700, X03401594, X04411243, X10440050, and, X10440392 SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02930, Lot Numbers: X01383007, X04411242, and X06429052, SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02935, Lot Numbers: X01383008, X01383656, X02388611, X03401595, X06429053, and X10441192 SHELL SCREW D=5.5 L=40 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02940, Lot Numbers: V01121498, X01383011, X01383657, X02388602, X04411245, and X06429054 SHELL SCREW D=5.5 L=45 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02945, Lot Numbers: X01383012, X01383658, X02388603, X03396701, and X04411246 SHELL SCREW D=5.5 L=50 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02950, Lot Numbers: X01383013, X02388604, X03396702, X04411247, and X10440396 SHELL SCREW D=5.5 L=55 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02955, Lot Numbers: X01383014, X02388605, and X10440398 SHELL SCREW D=5.5 L=60 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02960, Lot Numbers: X01383015, X02388606, X04401597, X06429055, and X10440399 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 1, PHA02976, Lot Numbers: X04388599 and X04396703 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 2, PHA02978, Lot Numbers: X02383653 and X04388600 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 3, PHA02980, Lot Number: W12372948 INSERT PLAT STANDARD A RETENTION 18 DEG T 32 G 3, PHA02986, Lot Number: X04388601 "PROFEMUR(R) E" HIP STEM SIZE 0 STD, PHA03140, Lot Numbers: U0366209 and U12115660 "PROFEMUR(R) E " HIP STEM SIZE 1 STD, PHA03141, Lot Number: X04396461 "PROFEMUR(R) E " HIP STEM SIZE 2 STD, PHA03142, Lot Numbers: V12300743 and X05401277 "PROFEMUR(R) E " HIP STEM SIZE 4 STD, PHA03144, Lot Number: U0266240 "PROFEMUR(R) E " HIP STEM SIZE 6 STD, PHA03146, Lot Number: V03156768 "PROFEMUR(R) E " HIP STEM SIZE 8 STD, PHA03148, Lot Number: W12383218 "PROFEMUR(R) E " HIP STEM SIZE 9 STD, PHA03149, Lot Numbers: W07334984 and X04401283 "PROFEMUR(R) E" HIP STEM SIZE 1 PLUS, PHA03161, Lot Numbers: W06314259 CRANIAL SCREW L=30 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03202, Lot Numbers: V02137447, W05321360, W05327910, and X03391272 CRANIAL SCREW L=35 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03204, Lot Numbers: W06327911, W10359182, W11372967, X06418488, and X09429068 CRANIAL SCREW L=40 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03206, Lot Numbers: W06335145, W10359183, X03391274, X04396748, and X06420323 CRANIAL SCREW L=45 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03208, Lot Numbers: W04321151, W05327690, W06335146, W11372968, X03376813, X03394306, X04396749, CX06418490, and X09429273 CRANIAL SCREW L=50 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03210, Lot Numbers: X06418491, X06420324, and X09440051 CRANIAL SCREW L=55 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03212, Lot number: X01383605 CRANIAL SCREW L=60 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03214, Lot Numbers: X01383606 and X09440052 FEMORAL STEM "CONTACT E" SIZE 1, PHA03302, Lot Number: X05396734 FEMORAL STEM "CONTACT E" SIZE 4, PHA03308, Lot Number: X03383623 FEMORAL STEM "CONTACT E" SIZE 5, PHA03310, Lot Number: X05388619 FEMORAL STEM "CONTACT E" SIZE 6, PHA03312, Lot Numbers: X01376820, X01378473, X04383625, X04388620, X05418498, and X07420259 FEMORAL STEM "CONTACT E" SIZE 7, PHA03314, Lot Numbers: W08350786, X01383626, X01386652, X04388613, X05418499, and X06420260 FEMORAL STEM "CONTACT E" SIZE 8, PHA03316, Lot Number: X04388614 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*42MM, PHA03604, Lot Numbers: W02317920, W04330182, and W07344145 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*44MM, PHA03606, Lot Numbers: W04330183, W07344146, and X04383554 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*56MM, PHA03618, Lot Numbers: W11376970, W11383159, and X04383560 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*58MM, PHA03620, Lot Numbers: W10350941 and X06428459 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*60MM, PHA03622, Lot Numbers: W04330191 and X04388633 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 44 TP & HAP, PHA04102, Lot Numbers: W02284047, W06321363, and W08334993 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 46 TP & HAP, PHA04104, Lot Number: W08334871 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 52 TP & HAP, PHA04110, Lot Number: W05309202 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 54 TP & HAP, PHA04112, Lot Number: V0385729 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 56 TP & HAP, PHA04114, Lot Numbers: V0385730, W05314708, W06321369, and W08327928 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 58 TP & HAP, PHA04116, Lot Numbers: U1286984, V10204652, W04301081, and W08334997 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 60 TP & HAP, PHA04118, Lot Numbers: U0870001, U0978318, U1186985, V05170004, V07204621, V10204653, V10244023, V11284844, W01257465, W01273565, W04288246, and W10360683 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 62 TP & HAP, PHA04120, Lot Numbers: V12244024, W01257466, W02278812, and W05321371 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 64 TP & HAP, PHA04122, Lot Numbers: U0670005, U1285734, V04153045, V07170006, V07186608, V12244025, and W04278813 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S, PHA04403, Lot Numbers: X01391214, X02391457, X03401202, X03416534, X04420341, X05429760, X05433391, X05433392, X06433393, X10429130, X10441095, X10453674, and X10472722 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M, PHA04404, Lot Numbers: X02391215, X02391458, X02408873, X02408874, X03401203, X04405574, X05419576, X06429131, X07443009, X10445480, X10453230, and X10473195 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L, PHA04406, Lot Numbers: W09376007, X01391216, X02391459, X02408872, X03401204, X04405573, X05433397, X06419577, X06433398, X07443007, X09458368, X09472725, X10429132, X10445479, and X10458369 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S, PHA04408, Lot Numbers: X02391460, X04419578, X05426391, X06443003, X06443004, X09441098, and X10429133 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M, PHA04410, Lot Numbers: X02401120, X03408539, X05419579, X06420345, X06443001, and X07429134 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L, PHA04412, Lot Numbers: W11385712, X03401173, X10429135, X10441100, and X10453172 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S, PHA04414, Lot Numbers: X01391188 and X05420347 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L, PHA04418, Lot Number: X10441103 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 S (-4), PHA04465, Lot Numbers: X09441093 and X09441107 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 M (0), PHA04466, Lot Numbers: X02407368, X03413912, X04413915, X05420350, X10441094, and X10441105 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 L (+4), PHA04468, Lot Numbers: X03413910, X03413913, X04413916, and X10441106 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP A, PHA04502, Lot Numbers: X03391192, X03391374, X06429111, X09443000, X10440439, and X10473184 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP B, PHA04504, Lot Numbers: X01391126, X02391375, X05429112, X06440440, and X08453672 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, PHA04506, Lot Number: X04405562 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP D, PHA04508, Lot Number: X06440442 RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP G, PHA04514, Lot Numbers: W12383958, X02391131, X03391380, X03405548, X04405565, and X05435509 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP B, PHA04604, Lot Numbers: X02391152, X04391416, and X08420330 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP C, PHA04606, Lot Numbers: X01391153, X03398168, and X06398204 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP D, PHA04608, Lot Numbers: X01391154, X03398169, and X06398205 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP E, PHA04610, Lot Numbers: X02391155, X03398170, and X06398206 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP F, PHA04612, Lot Numbers: X03398171 and X06398207 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP G, PHA04614, Lot Numbers: X01391157, X03398172, and X06398208 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP B, PHA04654, Lot Numbers: X01391159, X06419574, and X06428700 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP C, PHA04656, Lot Numbers: X03398173, X04398209, and X08420325 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP D, PHA04658, Lot Numbers: X01391161, X03398174, X04398210, X06419575, and X08420326 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP E, PHA04660, Lot Numbers: X02391162, X03398175, X05398211, and X08420328 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP F, PHA04662, Lot Numbers: X02391163, X03398176, X05398212, X06420074, and X08420329 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP G, PHA04664, Lot Numbers: W11383976, X01391164, X03398177, and X06398213 PROFEMUR(R) L HIP STEM SIZE 1 , PHA05502, Lot Numbers: U1187531, V03141654, V07220443, W02288294, W03301272, W05321409, W10359049, X06410992, and X09420103 PROFEMUR(R) L HIP STEM SIZE 2 , PHA05504, Lot Numbers: V04141655, W09359029, W10359380, W11372754, W11376963, X02383508, X03396472, X04401291, and X06410993 PROFEMUR(R) L HIP STEM SIZE 3 , PHA05506, Lot Numbers: X04396473 and X07420105 PROFEMUR(R) L HIP STEM SIZE 4 , PHA05508, Lot Numbers: V04192902 and X04396474 PROFEMUR(R) L HIP STEM SIZE 8 , PHA05516, Lot Numbers: V04141659, W03309102, W05328358, and X02393430 PROFEMUR(R) L HIP STEM SIZE 9 , PHA05518, Lot Numbers: U0674034, U0674036, U0983018, U1177341, U12141640, V04141660, V04150753, V12254742, W02309103, W03309395, W05321415, W07350665, W10359033, W10359387, X01376966, X02383515, X02393431, and X09420111 PROFEMUR(R) L HIP STEM SIZE 10 , PHA05520, Lot Numbers: U0674037, U0677343, U0774038, U1183019, U1287540, V04141661, V04150754, W01288297, W03309104, W05309396, W10372849, W11372762, X01383133, X04383516, X04396330, X04401299, and X10420112 PROFEMUR(R) L HIP STEM SIZE 11 , PHA05522, Lot Numbers: U0674040, U0777345, U0777346, U1283075, U1287541, V01141641, V04141662, V04150755, W03288298, W04301279, W04314911, W05309397, W10372850, X01383517, and X05396480 STEM "PROFEMUR(R) XM" SIZE 0 CR/CO CEMENTED, PHA06000, Lot Number: W12380360 STEM "PROFEMUR(R) XM" SIZE 1 CR/CO CEMENTED, PHA06002, Lot Numbers: W07335073 and W08344355 STEM "PROFEMUR(R) XM" SIZE 2 CR/CO CEMENTED, PHA06004, Lot Numbers: X01380361 and X05398908 STEM "PROFEMUR(R) XM" SIZE 3 CR/CO CEMENTED, PHA06006, Lot Numbers: W11372855 and X05393433 STEM "PROFEMUR(R) XM" SIZE 4 CR/CO CEMENTED, PHA06008, Lot Numbers: W11372856 and X10401304 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.42 GROUP A, PHA06202, Lot Numbers: X03391132, X04391388, and X08418567 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.44 GROUP B, PHA06204, Lot Numbers: X02391133, X03391389, and X06401361 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.46 GROUP C, PHA06206, Lot Numbers: X02391193, X05398958, and X08401620 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.48 GROUP C, PHA06208, Lot Number: W09354559 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.50 GROUP D, PHA06210, Lot Number: X04391392 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.58 GROUP F, PHA06218, Lot Numbers: X05391396 and X07398963 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.60 GROUP G, PHA06220, Lot Numbers: X01383993, X03391220, and X07401659 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.62 GROUP G, PHA06222, Lot Numbers: X01383966, X03391200, X04391397, X05398964, and X07401625 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.64 GROUP G, PHA06224, Lot Numbers: X02391134, X04391398, X06401363, and X07418589 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.66 GROUP G, PHA06226, Lot Numbers: X02391135, X04391399, X06418500, X07401364, and X07418590 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.68 GROUP G, PHA06228, Lot Numbers: X03391136, X04391400, X06401365, and X07418591 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 42 GRP A, PHA06252, Lot Numbers: X05391137 and X10432055 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 44 GRP B, PHA06254, Lot Numbers: X05391138 and X07398190 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 46 GRP C, PHA06256, Lot Numbers: X05391139, X07391139, X07391403, and X07398192 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 58 GRP F, PHA06268, Lot Number: X05391145 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 60 GRP G, PHA06270, Lot Number: X05391146 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 62 GRP G, PHA06272, Lot Numbers: X05391147 and X05391411 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 64 GRP G, PHA06274, Lot Numbers: X05391148, X07391412, and X07398201 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 66 GRP G, PHA06276, Lot Numbers: X05391149, X09398202, and X10391413 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 68 GRP G, PHA06278, Lot Numbers: X05391150 and X09398203 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.42 GROUP A, PHA06402, Lot Numbers: X03391165, X05391429, X06401366, and X10419174 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.44 GROUP B, PHA06404, Lot Numbers: X03391166, X04391430, X05401367, and X10419175 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.46 GROUP C, PHA06406, Lot Numbers: X04391431, X06401373, and X10419176 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.48 GROUP C, PHA06408, Lot Numbers: X05410664 and X06401370 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.50 GROUP D, PHA06410, Lot number: X04391433 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.54 GROUP E, PHA06414, Lot number: X05401371 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.58 GROUP F, PHA06418, Lot number X04398971 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.60 GROUP G, PHA06420, Lot Numbers: X04410179 and X10418603 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.62 GROUP G, PHA06422, Lot Numbers: X02383982, X03391209, X04391439, X04413940, and X06401629 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.64 GROUP G, PHA06424, Lot Numbers: X03391172, X04391440, X06401651, and X10418606 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.66 GROUP G, PHA06426, Lot Numbers: X03391173, X04391441, X06401630, and X10419184 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.68 GROUP G, PHA06428, Lot Numbers: X03391174, X05391442, X06401631, and X10419185 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 42 GRP A, PHA06452, Lot Numbers: X04391175, X05394312, and X05401632 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 44 GRP B, PHA06454, Lot number: X05401633 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 46 GRP C, PHA06456, Lot number: X05401634 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 56 GRP F, PHA06466, Lot number: X05391450 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 58 GRP F, PHA06468, Lot number: W10356967 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 60 GRP G, PHA06470, Lot Numbers: W10356968 and X05410645 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 62 GRP G, PHA06472, Lot Numbers: W10356969, X04383992, and X05401356 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 64 GRP G, PHA06474, Lot Numbers: X04391183, X05391454, and X05401357 CUP "PROCOTYL(R) C" SIZE 56*36 , PHA06612, Lot Number: X03402654 CUP "PROCOTYL(R) C" SIZE 58*36 , PHA06614, Lot Numbers: X03406678 and X05413349 CUP "PROCOTYL(R) C" SIZE 60*36 , PHA06616, Lot Numbers: X03406679 and X05413350 CUP "PROCOTYL(R) C" SIZE 62*36 , PHA06618, Lot Numbers: X03406680 and X05413352 CUP "PROCOTYL(R) C" SIZE 64*36 , PHA06620, Lot Numbers: X03402655 and X05413344 COTYLE "ANCA" SANS TROUS N/REVET. HAP 42, PPR67162, Lot Number: X0419231 COTYLE "ANCA" SANS TROUS N/REVET. HAP 44, PPR67164, Lot Numbers: W02274744, X05437424, X05437426, and X05438571 COTYLE "ANCA" SANS TROUS N/REVET. HAP 46, PPR67166, Lot Numbers: W12359260, X01383050, X04385824, and X04396717 COTYLE "ANCA" SANS TROUS N/REVET. HAP 48, PPR67168, Lot Numbers: X05396718 and X07401501 COTYLE "ANCA" SANS TROUS N/REVET. HAP 50, PPR67170, Lot Numbers: X04385823, X04388622, and X05396719 COTYLE "ANCA" SANS TROUS N/REVET. HAP 52, PPR67172, Lot Numbers: W02278985, W02288422, W07335010, X05401153, and X07401503 COTYLE "ANCA" SANS TROUS N/REVET. HAP 56, PPR67176, Lot Number: U1272106 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 42, PPR67468, Lot Numbers: X06438566, X06438567, X06438835, X06438837, and X06438838 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 44, PPR67470, Lot Numbers: X04117783, X06438569, X06438844, X07401510, and X07449511 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 58, PPR67484, Lot Numbers: X02383055, X05388624, X06396716, and X07420050 INSERT CERAM "ANCA FIT(TM)" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, Lot Numbers: X02400093, X02412719, X09474407, and X09474408 INSERT CERAM "ANCA FIT(TM)" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, Lot Numbers: X02395922, X02406670, X03396561, X03401607, X04420195, X10440215, X10473189, and X10473190 INSERT CERAM "ANCA FIT(TM)" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, PPR67512, Lot Numbers: V06202398, X03388678, X04401608, X04419027, X05428895, X09435512, X10440216, and X10473180 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5D, PPR67600, Lot Numbers: U0670969, U0679765, U0887659, U1280676, W10373028, and W11385761 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5G, PPR67602, Lot Numbers: U0575101, U0672481, U0787660, U1279919, V09244130, V0963602, V11272593, W01300826, W05314775, and X01385762 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11D, PPR67604, Lot Numbers: U0364898, U0887661, U1292236, V04136962, and V09239153 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11G, PPR67606, Lot Numbers: U0568633, U0579766, U0787662, U0872482, U1180679, V04141692, and X10428876 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12D, PPR67608, Lot Numbers: U1296090 and V09244132 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12G, PPR67610, Lot Numbers: X02388726 and X05419035 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13D, PPR67612, Lot Number: W10359266 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13G, PPR67614, Lot Numbers: U1087664 and V10260149 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14D, PPR67616, Lot Numbers: V02132308, V08239159, V10254654, and W03314772 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14G, PPR67618, Lot Numbers: W03309252, W10373036, and X04401521 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15D, PPR67620, Lot Numbers: W04309248 and X09428873 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15G, PPR67622, Lot Numbers: U0368396, U0780692, V02141669, V09215517, W03301156, X01383727, X02388735, X04401523, X05420183, and X06419041 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16D, PPR67624, Lot Numbers: U0975096, V02136969, V0331275, V04156917, V0451269, V07185912, V09273907, V11272599, W01288425, W02301164, W04314333, W09359269, W10373038, W11376877, W11383061, X02383721, X03393461, X04396526, X05420178, and X07428874 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16G, PPR67626, Lot Numbers: U0664915, V0440521, V06202413, V10272600, V11278907, W01288341, W01308058, W0140521, W02301157, W04314780, W11376884, X02388736, and X07420184 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5D, PPR67628, Lot Numbers: U0768644, U0778884, V03185938, V0431283, V09254656, V10281949, W01308060, W01308061, W01308062, W04306670, W09364719, W09374391, W10376707, and X0195958 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5G, PPR67630, Lot Numbers: W01308064, W01308068, W0966209, and X02396549 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 9.5D (POLIE), PPR70000, Lot Number: X0543024110 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11D (POLIE), PPR70004, Lot Number: X04419060 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11G (POLIE), PPR70006, Lot Number: X01388737 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12D (POLIE), PPR70008, Lot Number: X04419062 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12G (POLIE), PPR70010, Lot Numbers: X01388721, X02396846, and X05428441 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13D (POLIE), PPR70012, Lot Numbers: V01121619, X05420170, and X09428857 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13G (POLIE), PPR70014, Lot Numbers: W10373044, X0339651610, X04419065, X05420172, and X09428864 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14D (POLIE), PPR70016, Lot Number: X02388722 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14G (POLIE), PPR70018, Lot Numbers: X04419067 and X05428442 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15D (POLIE), PPR70020, Lot Numbers: X01372772, X04419068, and X05420171 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15G (POLIE), PPR70022, Lot Numbers: X04401538, X04419069, and X05428444 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 17.5 LEFT, PPR72216, Lot Number: X03388712 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 16 RIGHT, PPR72234, Lot Number: X02388703 COTYLE "MULLER" A RETENTION 48*28, PPT01554, Lot Number: X05401328 COTYLE TYPE "MULLER" 44*28 , PPT02000, Lot Numbers: V09187401, W1182815, and X07401331 COTYLE TYPE "MULLER" 50*28 , PPT02300, Lot Number: X07401333 COTYLE TYPE "MULLER" 52*28 , PPT02302, Lot Numbers: X02402650 and X07401334 COTYLE TYPE "MULLER" 54*28 , PPT02400, Lot Number: X06396793 COTYLE TYPE "MULLER" 56*28 , PPT02402, Lot Number: X02402649 COTYLE TYPE "MULLER" 58*28 , PPT02500, Lot Number: X07401337 COTYLE TYPE "MULLER" 60*28 , PPT02501, Lot Number: X01388420 COTYLE TYPE "MULLER" 62*28 , PPT02502, Lot Number: X02402682 TETE FEMORALE 22 CM 12/14 CR/CO (0), PPT07032, Lot Numbers: W12376919, W12383538, X02391324, X04396795, X05396796, X05401639, X09419076, X09420351, X10428704, and X10428705 TETE FEMORALE 22 CL 12/14 CR/CO (+3.5), PPT07034, Lot Numbers: V06215393, W12383540, X01376920, X02391326, X02391327, X04396797, X05401340, X05419077, and X09419078 TETE A JUPE 22 CC 12/14 CR/CO (-3.5), PPT08110, Lot Number: X02383083 TETE A JUPE 22 CL 12/14 CR/CO (+3.5), PPT08114, Lot Number: X02383084 TETE FEMORALE 28 CM 14/16 CR/CO (0), PPT08600, Lot Number: X09440057 TETE FEMORALE 28 CL 14/16 CR/CO (+3.5), PPT08700, Lot Number: X09429157 TETE FEMORALE 28 CC 12/14 CR/CO (-3.5), PPT08710, Lot Numbers: U12116264, X01376909, X02391468, and X05411293 TETE FEMORALE 28 CM 12/14 CR/CO (0), PPT08712, Lot Numbers: X01391328 and X10440481 TETE FEMORALE 28 CL 12/14 CR/CO (+3.5), PPT08714, Lot Numbers: W01288441, X01376914, X01390673, and X05411373 TETE FEMORALE 28 EXL 12/14 CR/CO (+7), PPT08715, Lot Numbers: W10321555, X01383526, and X06391334 TETE FEMORALE 32 CC 14/16 CR/CO (-4), PPT09310, Lot Numbers: X01396350 and X02401177 TETE FEMORALE 32 CL 14/16 CR/CO (+4), PPT09312, Lot Numbers: X01391338, X0219810, X02401179, and X07401346 TETE FEMORALE 32 CC 12/14 CR/CO (-4), PPT09320, Lot Numbers: X01383527, X01391339, and X04396816 TETE FEMORALE 32 CM 12/14 CR/CO (0), PPT09322, Lot Numbers: X01383528, X01391340, and X04396768 TETE FEMORALE 32 CL 12/14 CR/CO (+4), PPT09324, Lot Numbers: X01391341 and X06396769 TETE FEMORALE 32 CC 12/14 CERAMIQUE AL2.O3, PPT10240, Lot Numbers: W12383531, W12395618, X01391483, X02403646, X05429126, X07435527, and X07440466 TETE FEMORALE 32 CM 12/14 CERAMIQUE AL2.O3, PPT10242, Lot Numbers: W12390616, W12395612, X01391484, X02403643, X03410193, X04419084, X05420339, X05426395, and X10445478 TETE FEMORALE 32 CL 12/14 CERAMIQUE AL2.O3, PPT10244, Lot Numbers: W11389001, W12383533, X01403644, X02396819, X02403645, X03410196, X04419085, X05426394, and X09429128 CUPULE MOBILE A BAGUE DE MAINTIEN D=40/22, PPT17000, Lot Numbers: X02383452 and X06421738 CUPULE MOBILE A BAGUE DE MAINTIEN D=43/22, PPT17003, Lot Numbers: V0397724 and X09420214 CUPULE MOBILE A BAGUE DE MAINTIEN D=45/28, PPT17005, Lot number: W05321489 CUPULE MOBILE A BAGUE DE MAINTIEN D=46/28, PPT17006, Lot Numbers: W02301213 and W04321170 CUPULE MOBILE A BAGUE DE MAINTIEN D=49/28, PPT17009, Lot Numbers: X02383457, X06401648, and X09419099 CUPULE MOBILE A BAGUE DE MAINTIEN D=51/28, PPT17011, Lot Numbers: X02383095 and X06419101 CUPULE MOBILE A BAGUE DE MAINTIEN D=52/28, PPT17012, Lot Numbers: X02383478, X03396733, X06401318, and X09419102 CUPULE MOBILE A BAGUE DE MAINTIEN D=53/28, PPT17013, Lot Numbers: X02396373 and X07410931 CUPULE MOBILE A BAGUE DE MAINTIEN D=54/28, PPT17014, Lot Numbers: W12376926, X02383458, X04396724, and X07401319 CUPULE MOBILE A BAGUE DE MAINTIEN D=55/28, PPT17015, Lot Numbers: X03373065, X04396725, X07419105, and X07420226 CUPULE MOBILE A BAGUE DE MAINTIEN D=56/28, PPT17016, Lot Numbers: X0197891A, X03396726, X03408880, X07419106, and X09420227 CUPULE MOBILE A BAGUE DE MAINTIEN D=57/28, PPT17017, Lot Numbers: X06410933 and X07420228 CUPULE MOBILE A BAGUE DE MAINTIEN D=58/28, PPT17018, Lot Numbers: W11344310 and X09420229 CUPULE MOBILE A BAGUE DE MAINTIEN D=59/28, PPT17019, Lot Numbers: X03383459 and X06396727 CUPULE MOBILE A BAGUE DE MAINTIEN D=60/28, PPT17020, Lot Numbers: W06335038, W12383096, and X07419109 VIS A COTYLE D5.5 L=15 "ANCA" , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 "ANCA" , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 "ANCA" , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR "ANCA" SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 "ANCA" , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 "ANCA" , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 "ANCA" , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 "ANCA" , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 "ANCA" , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION "ULTIME" HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM "ULTIME" STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM "ULTIME" STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM "ULTIME" STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM "ULTIME" STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503, X03396425, X05401264, X05409723, and X07420122 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 15, PPW38005, Lot Numbers: X02388504, X02401703, X05409724, X07418382, and X10420123 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 16, PPW38006, Lot Numbers: X03396285, X03396427, and X06401265 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 17, PPW38007, Lot Number: X07418384 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 18, PPW38008, Lot Numbers: X05409725, X06401711, and X07418385 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 19, PPW38009, Lot Numbers: V11292269, X01401721, X02388505, X03396428, X05409726, X06401719, X06401722, and X07418386 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 20, PPW38010, Lot Numbers: W01300721, X04409727, X05100883, and X05401723 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 21, PPW38011, Lot Numbers: V11290488, W12100884, X01401724, X01401726, X05409728, X06401728, and X07418387, PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 22, PPW38012, Lot Numbers: X01401731, X05409729, X06100885, X06100885A, X06401729, and X07418388 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 10, PPW38020, Lot Numbers: X01383191, X02388517, X03396445, X05401266, and X05418389 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 11, PPW38021, Lot Numbers: X02388506, X04396437, X05409730, and X05418390 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 12, PPW38022, Lot Numbers: X01388507, X04409731, X05418391, and X07420124 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 13, PPW38023, Lot Numbers: X05418392 and X10428808 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 14, PPW38024, Lot Numbers: X01388421, X02388509, and X03396440 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 15, PPW38025, Lot Numbers: X02388510 and X03396441 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 16, PPW38026, Lot Numbers: X02388511, X05409733, and X05418395 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 17, PPW38027, Lot Numbers: X02388512, X03396442, and X05418396 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 18, PPW38028, Lot Numbers: X01383194, X02388513, X05409734, X05418397, and X07428418 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 19, PPW38029, Lot Numbers: V12277782, X01388514, X05409735, and X05418398 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 20, PPW38030, Lot Numbers: V12301619, W10372765, X03388515, X05418399, and X07428419 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 21, PPW38031, Lot Numbers: X05409736 and X05418400 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 22, PPW38032, Lot Numbers: X02388516, X03396443, X03409737, and X05418401 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 10, PPW38040, Lot Numbers: V10271407, W10376686, X01383196, X03396444, X04401258, X05409738, and X09418402 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 11, PPW38041, Lot Numbers: W01287432, X01388487, X03396446, and X06418403 PROFEMUR(R) 215MM STEM BOWED TAPER SIZE 12, PPW38042, Lot Numbers: X01388422, X02388488, and X04409739 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 13, PPW38043, Lot Numbers: X01383197, X02388489, and X06418405 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 14, PPW38044, Lot Numbers: X0284416, X03396449, and X05418406 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 15, PPW38045, Lot Numbers: V12292277, W02300946, X01382943, X01383198, X02388491, X05396450, X05401259, and X06418407 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 16, PPW38046, Lot Numbers: V06227308, W02301470, W11383199, X01388492, X01396451, and X06418408 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 17, PPW38047, Lot Numbers: V12287435, X03418617, X04401260, and X05418409 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 18, PPW38048, Lot Numbers: X03401750, X03401763, X04409743, and X06418410 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 19, PPW38049, Lot Numbers: V11292256 and X05418411 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 20, PPW38050, Lot Numbers: W01111358, X01401765, X03401767, X05418412, and X09420126 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 21, PPW38051, Lot Numbers: X06418413 and X0791110 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 22, PPW38052, Lot Numbers: X01100887A, X0171384, X02397392, X03402993, X04418620, X05409744, and X07418414 "PROFEMUR(R) R" GRIT BLASTED PROX BODY XSMALL, PPW38058, Lot Numbers: V0171443, X03396492, X05401305, X05424421, and X08418416 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 1, PPW38061, Lot Numbers: X0795065.1 and W02112667 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3, PPW38063, Lot Numbers: W02110068 and W0375663 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4, PPW38064, Lot Number: W02110621 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 10.5, PPW38300, Lot Numbers: X04125745, X05409745, and X10420130 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 12, PPW38302, Lot Numbers: X05409746 and X09420131 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 13.5, PPW38304, Lot Numbers: X05396498, X05409747, and X09428420 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 15, PPW38306, Lot Numbers: V06227292, W12382947, W12383200, X03388494, X05100009X1, and X05396499 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 16.5, PPW38308, Lot Numbers: X05396500 and X09428421 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 18, PPW38310, Lot Number: W12382949 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 19.5, PPW38312, Lot Number: X09428422 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 21, PPW38314, Lot Number: X05409748 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 22.5, PPW38316, Lot Numbers: X04125877, X05409749, and X09420132 PROFEMUR(R) 175MM BOWED CYL PS SIZE 10.5, PPW38320, Lot Number: X05409750 PROFEMUR(R) 175MM BOWED CYL PS SIZE 12, PPW38322, Lot Numbers: X03396290, X05396501, and X05409751 PROFEMUR(R) 175MM BOWED CYL PS SIZE 13.5, PPW38324, Lot Numbers: W01300737, X04396502, and X05102041 PROFEMUR(R) 175MM BOWED CYL PS SIZE 15, PPW38326, Lot Numbers: X03396291 and X05396503 PROFEMUR(R) 175MM BOWED CYL PS SIZE 16.5, PPW38328, Lot Numbers: X03396292, X10396504, and X10439998 PROFEMUR(R) 175MM BOWED CYL PS SIZE 18, PPW38330, Lot Numbers: X03382950, X03396293, and X05409752 PROFEMUR(R) 175MM BOWED CYL PS SIZE 19.5, PPW38332, Lot Numbers: X05409753 and X10428423 PROFEMUR(R) 175MM BOWED CYL PS SIZE 21, PPW38334, Lot Numbers: X05409754 and X10428424 PROFEMUR(R) 175MM BOWED CYL PS SIZE 22.5, PPW38336, Lot Numbers: V07100720, X05121256, X05409755, and X10420134 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY X-SMALL MODULAR, PPW38354, Lot number: X09401306 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY SMALL, PPW38360, Lot Number: U1078950 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 1, PPW38361, Lot Number: W12382952 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 2, PPW38362, Lot Numbers: X04396506 and X09401251 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 3, PPW38363, Lot Numbers: X02382954, X04396507, and X08409756 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 4, PPW38364, Lot Numbers: W12382955, X02383204, X02385735, and X05409757 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY LARGE, PPW38365, Lot Number: X05409758 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ10.5, PPW38370, Lot Numbers: U0463053, W01100739, X03396294, and X05409759 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 12, PPW38372, Lot Numbers: X03396295 and X05409760 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 15, PPW38376, Lot Number: X03396297 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ16.5, PPW38378, Lot Numbers: X05409761 and X09428425 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 18, PPW38380, Lot Numbers: X05409762 and X09428426 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ19.5, PPW38382, Lot Numbers: X04125896, X05409763, and X10428427 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ 21, PPW38384, Lot Numbers: X05125897, X05409764, and X10420141 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ22.5, PPW38386, Lot Numbers: X05409765 and X10428428 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SZ 12, PPW38404, Lot Number: X04100973 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38410, Lot Number: X0239629910 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38422, Lot Number: X04409768 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 12, PPW38424, Lot Numbers: W01300738, X04100971, and X04100978 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38430, Lot Numbers: X05100968 and X05409769 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 18, PPW38432, Lot Number: X05409770 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38442, Lot Number: X05410188 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 15, PPW38448, Lot Numbers: X02396302 and X04409773 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 18, PPW38452, Lot Number: X04409774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 19.5, PPW38454, Lot Numbers: X04129583 and X04409775 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 21, PPW38456, Lot Numbers: X04129255, X04409776, and X05425774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 22.5, PPW38458, Lot Number: X04129256 TIGE PROXIM. MONOBLOC V4 EV1 "PROFEMUR(R) R" EX/SMALL, PPW39009, Lot Numbers: U01136593, U0665166, X08401542, and X09419124 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 2 V4, PPW39106, Lot Number : X05401544 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3 V4, PPW39108, Lot Numbers: W06328345, X02388522, X05409779, and X09419155 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4 V4, PPW39110, Lot Numbers: X01385799, X02388523, X03396485, X05401545, and X05409780 "PROFEMUR(R) R" GRIT BLASTED PROX BODY LARGE V4, PPW39112, Lot Numbers: X01383506, X02388524, X04396486, X05401546, and X08409782 "PROFEMUR(R) R" HA COATED PROX BODY SMALL V4, PPW39122, Lot Number: U0980429 "PROFEMUR(R) R" HA COATED PROX BODY STD 1 V4, PPW39124, Lot Number: V11244233 "PROFEMUR(R) R" HA COATED PROX BODY STD 2 V4, PPW39126, Lot Numbers: U1187740 and V11244234 "PROFEMUR(R) R" HA COATED PROX BODY STD 3 V4, PPW39128, Lot Numbers: V05143958, X04396496, and X09419148 "PROFEMUR(R) R" HA COATED PROX BODY STD 4 V4, PPW39130, Lot Numbers: U1180433, V02140197, W11359374, X04396497, X07401247, X09419149, and X09428831 "PROFEMUR(R) R" HA COATED PROX BODY LARGE V4, PPW39132, Lot Numbers: W01278887, W06314895, W07328343, X07401248, and X09419150 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 00, PPX028059, Lot Number: X01350955 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 5, PPX028065, Lot Number: X02388557 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 3, PPX02873, Lot Numbers: X04404311 and X06420279 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 4, PPX02874, Lot Numbers: X03396831 and X05419133 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 5, PPX02875, Lot Numbers: X02383116, X02396342, and X03396832 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 6, PPX02876, Lot Numbers: X04388553 and X04396833 Orthopaedic INSERT MOBILE "COLLEGIA" TAILLE 58*28, OT22C58, Lot Numbers: W07335080 and X06391225 INSERT MOBILE "COLLEGIA" TAILLE 60*28, OT22C60, Lot Number: X06391226 TETE INOX "COLLEGIA" T 28/0 CONE 6 DEG. -N30NW-, OT32H28, Lot Numbers: 068573172 and X03396534 PROFEMUR(R) Z FEMORAL STEM S 1 CEMENT LESS, PHA00232, Lot Number: X05420041 PROFEMUR(R) Z FEMORAL STEM S 5 CEMENT LESS, PHA00240, Lot Number: V03156757 PROFEMUR(R) Z FEMORAL STEM S 8 CEMENT LESS, PHA00246, Lot Number: X05410982 PROFEMUR(R) Z FEMORAL STEM S 9 CEMENT LESS, PHA00248, Lot Numbers: V01132375, W03314591, X01383213, X02388533, X03396459, X04401274, and X07428776 REVISION SHELL "PROCOTYL(R) E" SIZE 52/60 G1 T/P COATED, PHA00370, Lot Number: X10410887 REVISION SHELL "PROCOTYL(R) E" SIZE 54/62 G1 T/P COATED, PHA00372, Lot Number: X05391267 REVISION SHELL "PROCOTYL(R) E" SIZE 56/64 G1 T/P COATED, PHA00374, Lot Number: X10418370 REVISION SHELL "PROCOTYL(R) E" SIZE 60/68 G2 T/P COATED, PHA00378, Lot Number: X10410890 REVISION SHELL "PROCOTYL(R) E" SIZE 62/70 G2 T/P COATED, PHA00380, Lot Number: X04391099 REVISION SHELL "PROCOTYL(R) E" SIZE 64/72 G2 T/P COATED, PHA00382, Lot Numbers: V07227366, X01372961, X02383420, and X10410892 REVISION SHELL "PROCOTYL(R) E" SIZE 66/74 G3 T/P COATED, PHA00384, Lot Numbers: X05391100 and X05391265 REVISION SHELL "PROCOTYL(R) E" SIZE 68/76 G3 T/P COATED, PHA00386, Lot Number: X01372963 STEM REVISION "PROFEMUR(R) Z" SIZE 3, PHA00606, Lot Numbers: X01399395, X03393766, and X04393775 STEM REVISION "PROFEMUR(R) Z" SIZE 4, PHA00608, Lot Numbers: X02399397, X03393767, and X04393776 STEM REVISION "PROFEMUR(R) Z" SIZE 5, PHA00610, Lot Numbers: X03393768, X03399398, X03400451, X04393777, and X04400452 STEM REVISION "PROFEMUR(R) Z" SIZE 6, PHA00612, Lot Numbers: W12238302, X03393769, X03399400, X03400453, X04393778, and X04400454 STEM REVISION "PROFEMUR(R) Z" SIZE 7, PHA00614, Lot Numbers: X01238303, X03393770, X03399401, X03400455, X04393779, and X04400456 STEM REVISION "PROFEMUR(R) Z" SIZE 8, PHA00616, Lot Numbers: X01238304, X01399402, X03393771, X03400458, X04393780, and X04400459 STEM REVISION "PROFEMUR(R) Z" SIZE 9, PHA00618, Lot Numbers: X01238305, X03393772, X03399404, and X04393781 STEM REVISION "PROFEMUR(R) Z" SIZE 10, PHA00620, Lot Numbers: X02399405, X03393773, and X04393782 STEM REVISION "PROFEMUR(R) Z" SIZE 11, PHA00622, Lot Numbers: X02377571, X03393774, and X04393783 CROCHET POUR COTYLE "PROCOTYL(R) E" L=18 (VERSION 3, PHA01106, Lot Numbers: V0181677, X03391269, and X03396706 CROCHET POUR COTYLE "PROCOTYL(R) E" L=23 (VERSION 3, PHA01107, Lot Numbers: U0366131, V0271861, W11376812, and X03391270 ILIAC PLATE "L" SHAPE "PROCOTYL(R) E" LEFT, PHA01110, Lot Number: X05420073 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" LEFT, PHA01120, Lot Number: X03396709 ILIAC PLATE "T" SHAPE "PROCOTYL(R) E" RIGHT, PHA01122, Lot Numbers: W07327875, X03391271, and X06401587 ILIAC PLATE DOUBLE "PROCOTYL(R) E" LEFT 4 HOLES, PHA01134, Lot Number: X03396707 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 4 HOLES, PHA01144, Lot Number: X03396708 ILIAC PLATE DOUBLE "PROCOTYL(R) E" RIGHT 5 HOLES, PHA01145, Lot Number: X03396359 PROFEMUR(R) NECK NEUTRALSHORT SHORT, PHA01202, Lot Numbers: U0781477, V02143965, V05185849, and X06420151 PROFEMUR(R) NECK NEUTRAL LONG, PHA01204, Lot Numbers: U0671647 and X03396401 PROFEMUR(R) NECK A/R VAR/VAL 2 SHORT, PHA01212, Lot Numbers: U0681198, U1185239, W12383174, X01388472, X02396405, X04401230, and X05418352 PROFEMUR(R) NECK A/R VAR/VAL 2 LONG, PHA01214, Lot Numbers: W07334963, W09359069, X02388473, X02396406, X05401242, and X05418353 PROFEMUR(R) NECK A/R VAR/VAL 1 SHORT, PHA01222, Lot Numbers: W09359061, X03396407, X04401231, X10420159, and X10428842 PROFEMUR(R) NECK A/R VAR/VAL 1 LONG, PHA01224, Lot Numbers: U1185241, V06215432, X01388475, X02396408, X04401232, X05418355, and X10420160 PROFEMUR(R) NECK 8DG A/R SHORT, PHA01232, Lot Numbers: V08215433, X01383177, X02394358, X06418357, X07439692, and X08428844 PROFEMUR(R) NECK 8DG A/R LONG, PHA01234, Lot Numbers: X01383179, X02388478, X02396411, X03396412, X04401235, X04401236, X06418358, X06418359, and X07420162 PROFEMUR(R) NECK 15DG A/R SHORT, PHA01242, Lot Numbers: U0366352, V07215735, W12383180, X01388480, X0193876A, X04401237, X04418360, and X06420163 PROFEMUR(R) NECK 15DG A/R LONG, PHA01244, Lot Numbers: U0366343, X01383182, X02388481, X02396414, X03401238, X04410875, X05418362, X06418361, and X07420164 PROFEMUR(R) NECK 8DG VAR/VAL SHORT, PHA01252, Lot Numbers: W11385750, X05418363, and X07418365 PROFEMUR(R) NECK 8DG VAR/VAL LONG, PHA01254, Lot Numbers: V06185863, X01383187, X01385844, X01388485, X04401243, X04401244, X05418366, X06418367, and X07420167 COTYLE "EHS-E" S/CIMENT S/REVET. T.56*41 18 DEG G2, PHA01956, Lot Number: X04396684 INSERT CERAMIQUE 18° 28/37G T 28 GROUPE 1 BIOLOX FORTE, PHA02046, Lot Numbers: X02400415, X04427560, X05429759, X07429026, and X10459182 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02052, Lot Numbers: X01383643, X02388588, X02396690, X03401463, X04416678, X05420309, and X05427559 INSERT CERAMIQUE 18° 28/41G T 28 GROUPE 2 BIOLOX FORTE, PHA02058, Lot Numbers: X03416959, X04428692, X06429028, and X09440377 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 1, PHA02246, Lot Numbers: X01383000, X02383646, X03388589, X04396691, and X07420310 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 2, PHA02252, Lot Numbers: X02383647, I X02388433, X03388590, X04396692, X05401465, X07418475, and X07420311 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 3, PHA02258, Lot Numbers: X02388434, X05401466, and X07429040 INSERT PLAT STANDARD 18 DEG T 28 GROUPE 4, PHA02264, Lot Numbers: U0366160, V11289411, and V12289425 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 2, PHA02352, Lot Numbers: X05401467 and X07418477 INSERT PLAT STANDARD 18 DEG T 32 GROUPE 3, PHA02358, Lot Number: X02383648 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G1, PHA02546, Lot Number: X06418478 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G2, PHA02552, Lot Numbers: W01272753, W01289415, W04314279, W12376869, X04396693, X08418479, and X08420314 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 28 G3, PHA02558, Lot Numbers: U0668153, W12378518, X01383651, X03388595, X04396694, and X07418481 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G2, PHA02652, Lot Numbers: X04388596, X04396695, and X05401471 INSERT DEBORD=15 DEG. STANDARD 18 DEG T 32 G3, PHA02658, Lot Numbers: X03396357, X05418482, and X07428694 INSERT CERAMIQUE 18° 32/41G T 32 GROUPE 2 BIOLOX FORTE, PHA02852, Lot Numbers: X02388598, X02411905, X03401590, PHA02852, X03411906, X05429029, and X06435536 INSERT CERAMIQUE 18° 32/48G T 32 GROUPE 3 BIOLOX FORTE, PHA02858, Lot Numbers: W12389006, W12395616, X0138859, X0139592, X02396697,X03401591, X03411904, and X05418484 INSERT CERAMIQUE 18° 32/52G T 32 GROUPE 4 BIOLOX FORTE, PHA02864, Lot Numbers: X01400420, X01402627, X04428395, and X09473192 SHELL SCREW D=5.5 L=15 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02915, Lot Numbers: X02388607, X02396698, X04401592, X04410964, X06428695, andX06429049 SHELL SCREW D=5.5 L=20 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02920, Lot Numbers: X03401593, X04410965, and X06429050 SHELL SCREW D=5.5 L=25 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02925, Lot Numbers: U0370883, U1085036, W04314684, X01383654, X02388609, X03396700, X03401594, X04411243, X10440050, and, X10440392 SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02930, Lot Numbers: X01383007, X04411242, and X06429052, SHELL SCREW D=5.5 L=30 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02935, Lot Numbers: X01383008, X01383656, X02388611, X03401595, X06429053, and X10441192 SHELL SCREW D=5.5 L=40 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02940, Lot Numbers: V01121498, X01383011, X01383657, X02388602, X04411245, and X06429054 SHELL SCREW D=5.5 L=45 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02945, Lot Numbers: X01383012, X01383658, X02388603, X03396701, and X04411246 SHELL SCREW D=5.5 L=50 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02950, Lot Numbers: X01383013, X02388604, X03396702, X04411247, and X10440396 SHELL SCREW D=5.5 L=55 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02955, Lot Numbers: X01383014, X02388605, and X10440398 SHELL SCREW D=5.5 L=60 SPHERICAL HEAD D=8 -HEX 3.5-, PHA02960, Lot Numbers: X01383015, X02388606, X04401597, X06429055, and X10440399 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 1, PHA02976, Lot Numbers: X04388599 and X04396703 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 2, PHA02978, Lot Numbers: X02383653 and X04388600 INSERT PLAT STANDARD A RETENTION 18 DEG T 28 G 3, PHA02980, Lot Number: W12372948 INSERT PLAT STANDARD A RETENTION 18 DEG T 32 G 3, PHA02986, Lot Number: X04388601 "PROFEMUR(R) E" HIP STEM SIZE 0 STD, PHA03140, Lot Numbers: U0366209 and U12115660 "PROFEMUR(R) E " HIP STEM SIZE 1 STD, PHA03141, Lot Number: X04396461 "PROFEMUR(R) E " HIP STEM SIZE 2 STD, PHA03142, Lot Numbers: V12300743 and X05401277 "PROFEMUR(R) E " HIP STEM SIZE 4 STD, PHA03144, Lot Number: U0266240 "PROFEMUR(R) E " HIP STEM SIZE 6 STD, PHA03146, Lot Number: V03156768 "PROFEMUR(R) E " HIP STEM SIZE 8 STD, PHA03148, Lot Number: W12383218 "PROFEMUR(R) E " HIP STEM SIZE 9 STD, PHA03149, Lot Numbers: W07334984 and X04401283 "PROFEMUR(R) E" HIP STEM SIZE 1 PLUS, PHA03161, Lot Numbers: W06314259 CRANIAL SCREW L=30 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03202, Lot Numbers: V02137447, W05321360, W05327910, and X03391272 CRANIAL SCREW L=35 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03204, Lot Numbers: W06327911, W10359182, W11372967, X06418488, and X09429068 CRANIAL SCREW L=40 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03206, Lot Numbers: W06335145, W10359183, X03391274, X04396748, and X06420323 CRANIAL SCREW L=45 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03208, Lot Numbers: W04321151, W05327690, W06335146, W11372968, X03376813, X03394306, X04396749, CX06418490, and X09429273 CRANIAL SCREW L=50 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03210, Lot Numbers: X06418491, X06420324, and X09440051 CRANIAL SCREW L=55 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03212, Lot number: X01383605 CRANIAL SCREW L=60 + LOCK SCREW FOR "PROCOTYL(R) E", PHA03214, Lot Numbers: X01383606 and X09440052 FEMORAL STEM "CONTACT E" SIZE 1, PHA03302, Lot Number: X05396734 FEMORAL STEM "CONTACT E" SIZE 4, PHA03308, Lot Number: X03383623 FEMORAL STEM "CONTACT E" SIZE 5, PHA03310, Lot Number: X05388619 FEMORAL STEM "CONTACT E" SIZE 6, PHA03312, Lot Numbers: X01376820, X01378473, X04383625, X04388620, X05418498, and X07420259 FEMORAL STEM "CONTACT E" SIZE 7, PHA03314, Lot Numbers: W08350786, X01383626, X01386652, X04388613, X05418499, and X06420260 FEMORAL STEM "CONTACT E" SIZE 8, PHA03316, Lot Number: X04388614 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*42MM, PHA03604, Lot Numbers: W02317920, W04330182, and W07344145 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 22*44MM, PHA03606, Lot Numbers: W04330183, W07344146, and X04383554 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*56MM, PHA03618, Lot Numbers: W11376970, W11383159, and X04383560 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*58MM, PHA03620, Lot Numbers: W10350941 and X06428459 LINER "ANCA-FIT(TM)" PE CROSS-LIN 10° 28*60MM, PHA03622, Lot Numbers: W04330191 and X04388633 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 44 TP & HAP, PHA04102, Lot Numbers: W02284047, W06321363, and W08334993 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 46 TP & HAP, PHA04104, Lot Number: W08334871 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 52 TP & HAP, PHA04110, Lot Number: W05309202 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 54 TP & HAP, PHA04112, Lot Number: V0385729 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 56 TP & HAP, PHA04114, Lot Numbers: V0385730, W05314708, W06321369, and W08327928 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 58 TP & HAP, PHA04116, Lot Numbers: U1286984, V10204652, W04301081, and W08334997 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 60 TP & HAP, PHA04118, Lot Numbers: U0870001, U0978318, U1186985, V05170004, V07204621, V10204653, V10244023, V11284844, W01257465, W01273565, W04288246, and W10360683 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 62 TP & HAP, PHA04120, Lot Numbers: V12244024, W01257466, W02278812, and W05321371 COTYLE DOUBLE MOBILITE "PROCOTYL(R) DM" T 64 TP & HAP, PHA04122, Lot Numbers: U0670005, U1285734, V04153045, V07170006, V07186608, V12244025, and W04278813 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 S, PHA04403, Lot Numbers: X01391214, X02391457, X03401202, X03416534, X04420341, X05429760, X05433391, X05433392, X06433393, X10429130, X10441095, X10453674, and X10472722 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 M, PHA04404, Lot Numbers: X02391215, X02391458, X02408873, X02408874, X03401203, X04405574, X05419576, X06429131, X07443009, X10445480, X10453230, and X10473195 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 28 L, PHA04406, Lot Numbers: W09376007, X01391216, X02391459, X02408872, X03401204, X04405573, X05433397, X06419577, X06433398, X07443007, X09458368, X09472725, X10429132, X10445479, and X10458369 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 S, PHA04408, Lot Numbers: X02391460, X04419578, X05426391, X06443003, X06443004, X09441098, and X10429133 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 M, PHA04410, Lot Numbers: X02401120, X03408539, X05419579, X06420345, X06443001, and X07429134 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 32 L, PHA04412, Lot Numbers: W11385712, X03401173, X10429135, X10441100, and X10453172 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 S, PHA04414, Lot Numbers: X01391188 and X05420347 FEMORAL HEAD BIOLOX DELTA CERAMIC 12/14 - 36 L, PHA04418, Lot Number: X10441103 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 S (-4), PHA04465, Lot Numbers: X09441093 and X09441107 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 M (0), PHA04466, Lot Numbers: X02407368, X03413912, X04413915, X05420350, X10441094, and X10441105 FEMORAL HEAD BIOLOX FORTE CERAMIC 12/14 - 36 L (+4), PHA04468, Lot Numbers: X03413910, X03413913, X04413916, and X10441106 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP A, PHA04502, Lot Numbers: X03391192, X03391374, X06429111, X09443000, X10440439, and X10473184 RIM-LOCK BIOLOX DELTA CERAMIC LINER 28 GROUP B, PHA04504, Lot Numbers: X01391126, X02391375, X05429112, X06440440, and X08453672 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP C, PHA04506, Lot Number: X04405562 RIM-LOCK BIOLOX DELTA CERAMIC LINER 32 GROUP D, PHA04508, Lot Number: X06440442 RIM-LOCK BIOLOX DELTA CERAMIC LINER 36 GROUP G, PHA04514, Lot Numbers: W12383958, X02391131, X03391380, X03405548, X04405565, and X05435509 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP B, PHA04604, Lot Numbers: X02391152, X04391416, and X08420330 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 28 GROUP C, PHA04606, Lot Numbers: X01391153, X03398168, and X06398204 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP D, PHA04608, Lot Numbers: X01391154, X03398169, and X06398205 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 32 GROUP E, PHA04610, Lot Numbers: X02391155, X03398170, and X06398206 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP F, PHA04612, Lot Numbers: X03398171 and X06398207 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 0° SIZE 36 GROUP G, PHA04614, Lot Numbers: X01391157, X03398172, and X06398208 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP B, PHA04654, Lot Numbers: X01391159, X06419574, and X06428700 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 28 GROUP C, PHA04656, Lot Numbers: X03398173, X04398209, and X08420325 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP D, PHA04658, Lot Numbers: X01391161, X03398174, X04398210, X06419575, and X08420326 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 32 GROUP E, PHA04660, Lot Numbers: X02391162, X03398175, X05398211, and X08420328 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP F, PHA04662, Lot Numbers: X02391163, X03398176, X05398212, X06420074, and X08420329 RIM-LOCK "A-CLASS(R)" ACETABULAR POLY LINER 15° SIZE 36 GROUP G, PHA04664, Lot Numbers: W11383976, X01391164, X03398177, and X06398213 PROFEMUR(R) L HIP STEM SIZE 1 , PHA05502, Lot Numbers: U1187531, V03141654, V07220443, W02288294, W03301272, W05321409, W10359049, X06410992, and X09420103 PROFEMUR(R) L HIP STEM SIZE 2 , PHA05504, Lot Numbers: V04141655, W09359029, W10359380, W11372754, W11376963, X02383508, X03396472, X04401291, and X06410993 PROFEMUR(R) L HIP STEM SIZE 3 , PHA05506, Lot Numbers: X04396473 and X07420105 PROFEMUR(R) L HIP STEM SIZE 4 , PHA05508, Lot Numbers: V04192902 and X04396474 PROFEMUR(R) L HIP STEM SIZE 8 , PHA05516, Lot Numbers: V04141659, W03309102, W05328358, and X02393430 PROFEMUR(R) L HIP STEM SIZE 9 , PHA05518, Lot Numbers: U0674034, U0674036, U0983018, U1177341, U12141640, V04141660, V04150753, V12254742, W02309103, W03309395, W05321415, W07350665, W10359033, W10359387, X01376966, X02383515, X02393431, and X09420111 PROFEMUR(R) L HIP STEM SIZE 10 , PHA05520, Lot Numbers: U0674037, U0677343, U0774038, U1183019, U1287540, V04141661, V04150754, W01288297, W03309104, W05309396, W10372849, W11372762, X01383133, X04383516, X04396330, X04401299, and X10420112 PROFEMUR(R) L HIP STEM SIZE 11 , PHA05522, Lot Numbers: U0674040, U0777345, U0777346, U1283075, U1287541, V01141641, V04141662, V04150755, W03288298, W04301279, W04314911, W05309397, W10372850, X01383517, and X05396480 STEM "PROFEMUR(R) XM" SIZE 0 CR/CO CEMENTED, PHA06000, Lot Number: W12380360 STEM "PROFEMUR(R) XM" SIZE 1 CR/CO CEMENTED, PHA06002, Lot Numbers: W07335073 and W08344355 STEM "PROFEMUR(R) XM" SIZE 2 CR/CO CEMENTED, PHA06004, Lot Numbers: X01380361 and X05398908 STEM "PROFEMUR(R) XM" SIZE 3 CR/CO CEMENTED, PHA06006, Lot Numbers: W11372855 and X05393433 STEM "PROFEMUR(R) XM" SIZE 4 CR/CO CEMENTED, PHA06008, Lot Numbers: W11372856 and X10401304 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.42 GROUP A, PHA06202, Lot Numbers: X03391132, X04391388, and X08418567 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.44 GROUP B, PHA06204, Lot Numbers: X02391133, X03391389, and X06401361 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.46 GROUP C, PHA06206, Lot Numbers: X02391193, X05398958, and X08401620 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.48 GROUP C, PHA06208, Lot Number: W09354559 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.50 GROUP D, PHA06210, Lot Number: X04391392 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.58 GROUP F, PHA06218, Lot Numbers: X05391396 and X07398963 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.60 GROUP G, PHA06220, Lot Numbers: X01383993, X03391220, and X07401659 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.62 GROUP G, PHA06222, Lot Numbers: X01383966, X03391200, X04391397, X05398964, and X07401625 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.64 GROUP G, PHA06224, Lot Numbers: X02391134, X04391398, X06401363, and X07418589 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.66 GROUP G, PHA06226, Lot Numbers: X02391135, X04391399, X06418500, X07401364, and X07418590 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED S.68 GROUP G, PHA06228, Lot Numbers: X03391136, X04391400, X06401365, and X07418591 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 42 GRP A, PHA06252, Lot Numbers: X05391137 and X10432055 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 44 GRP B, PHA06254, Lot Numbers: X05391138 and X07398190 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 46 GRP C, PHA06256, Lot Numbers: X05391139, X07391139, X07391403, and X07398192 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 58 GRP F, PHA06268, Lot Number: X05391145 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 60 GRP G, PHA06270, Lot Number: X05391146 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 62 GRP G, PHA06272, Lot Numbers: X05391147 and X05391411 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 64 GRP G, PHA06274, Lot Numbers: X05391148, X07391412, and X07398201 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 66 GRP G, PHA06276, Lot Numbers: X05391149, X09398202, and X10391413 ACETABULAR CUP "PROCOTYL(R) L" BEADED COATED+HAP 68 GRP G, PHA06278, Lot Numbers: X05391150 and X09398203 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.42 GROUP A, PHA06402, Lot Numbers: X03391165, X05391429, X06401366, and X10419174 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.44 GROUP B, PHA06404, Lot Numbers: X03391166, X04391430, X05401367, and X10419175 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.46 GROUP C, PHA06406, Lot Numbers: X04391431, X06401373, and X10419176 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.48 GROUP C, PHA06408, Lot Numbers: X05410664 and X06401370 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.50 GROUP D, PHA06410, Lot number: X04391433 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.54 GROUP E, PHA06414, Lot number: X05401371 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.58 GROUP F, PHA06418, Lot number X04398971 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.60 GROUP G, PHA06420, Lot Numbers: X04410179 and X10418603 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.62 GROUP G, PHA06422, Lot Numbers: X02383982, X03391209, X04391439, X04413940, and X06401629 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.64 GROUP G, PHA06424, Lot Numbers: X03391172, X04391440, X06401651, and X10418606 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.66 GROUP G, PHA06426, Lot Numbers: X03391173, X04391441, X06401630, and X10419184 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS COATED S.68 GROUP G, PHA06428, Lot Numbers: X03391174, X05391442, X06401631, and X10419185 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 42 GRP A, PHA06452, Lot Numbers: X04391175, X05394312, and X05401632 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 44 GRP B, PHA06454, Lot number: X05401633 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 46 GRP C, PHA06456, Lot number: X05401634 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 56 GRP F, PHA06466, Lot number: X05391450 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 58 GRP F, PHA06468, Lot number: W10356967 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 60 GRP G, PHA06470, Lot Numbers: W10356968 and X05410645 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 62 GRP G, PHA06472, Lot Numbers: W10356969, X04383992, and X05401356 ACETABULAR CUP "PROCOTYL(R) O" TI POROUS + HA COATED 64 GRP G, PHA06474, Lot Numbers: X04391183, X05391454, and X05401357 CUP "PROCOTYL(R) C" SIZE 56*36 , PHA06612, Lot Number: X03402654 CUP "PROCOTYL(R) C" SIZE 58*36 , PHA06614, Lot Numbers: X03406678 and X05413349 CUP "PROCOTYL(R) C" SIZE 60*36 , PHA06616, Lot Numbers: X03406679 and X05413350 CUP "PROCOTYL(R) C" SIZE 62*36 , PHA06618, Lot Numbers: X03406680 and X05413352 CUP "PROCOTYL(R) C" SIZE 64*36 , PHA06620, Lot Numbers: X03402655 and X05413344 COTYLE "ANCA" SANS TROUS N/REVET. HAP 42, PPR67162, Lot Number: X0419231 COTYLE "ANCA" SANS TROUS N/REVET. HAP 44, PPR67164, Lot Numbers: W02274744, X05437424, X05437426, and X05438571 COTYLE "ANCA" SANS TROUS N/REVET. HAP 46, PPR67166, Lot Numbers: W12359260, X01383050, X04385824, and X04396717 COTYLE "ANCA" SANS TROUS N/REVET. HAP 48, PPR67168, Lot Numbers: X05396718 and X07401501 COTYLE "ANCA" SANS TROUS N/REVET. HAP 50, PPR67170, Lot Numbers: X04385823, X04388622, and X05396719 COTYLE "ANCA" SANS TROUS N/REVET. HAP 52, PPR67172, Lot Numbers: W02278985, W02288422, W07335010, X05401153, and X07401503 COTYLE "ANCA" SANS TROUS N/REVET. HAP 56, PPR67176, Lot Number: U1272106 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 42, PPR67468, Lot Numbers: X06438566, X06438567, X06438835, X06438837, and X06438838 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 44, PPR67470, Lot Numbers: X04117783, X06438569, X06438844, X07401510, and X07449511 COTYLE "ANCA" AVEC TROUS N/REVET. HAP 58, PPR67484, Lot Numbers: X02383055, X05388624, X06396716, and X07420050 INSERT CERAM "ANCA FIT(TM)" 28/37 46-48/28 AL2.O3 BIOLOX FORTE, PPR67508, Lot Numbers: X02400093, X02412719, X09474407, and X09474408 INSERT CERAM "ANCA FIT(TM)" 28/40 50-52-54/28 AL2.O3 BIO. FORTE, PPR67510, Lot Numbers: X02395922, X02406670, X03396561, X03401607, X04420195, X10440215, X10473189, and X10473190 INSERT CERAM "ANCA FIT(TM)" 28/44 56-58/28 AL2.O3 BIOLOX FORTE, PPR67512, Lot Numbers: V06202398, X03388678, X04401608, X04419027, X05428895, X09435512, X10440216, and X10473180 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5D, PPR67600, Lot Numbers: U0670969, U0679765, U0887659, U1280676, W10373028, and W11385761 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 9.5G, PPR67602, Lot Numbers: U0575101, U0672481, U0787660, U1279919, V09244130, V0963602, V11272593, W01300826, W05314775, and X01385762 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11D, PPR67604, Lot Numbers: U0364898, U0887661, U1292236, V04136962, and V09239153 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 11G, PPR67606, Lot Numbers: U0568633, U0579766, U0787662, U0872482, U1180679, V04141692, and X10428876 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12D, PPR67608, Lot Numbers: U1296090 and V09244132 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 12G, PPR67610, Lot Numbers: X02388726 and X05419035 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13D, PPR67612, Lot Number: W10359266 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 13G, PPR67614, Lot Numbers: U1087664 and V10260149 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14D, PPR67616, Lot Numbers: V02132308, V08239159, V10254654, and W03314772 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 14G, PPR67618, Lot Numbers: W03309252, W10373036, and X04401521 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15D, PPR67620, Lot Numbers: W04309248 and X09428873 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 15G, PPR67622, Lot Numbers: U0368396, U0780692, V02141669, V09215517, W03301156, X01383727, X02388735, X04401523, X05420183, and X06419041 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16D, PPR67624, Lot Numbers: U0975096, V02136969, V0331275, V04156917, V0451269, V07185912, V09273907, V11272599, W01288425, W02301164, W04314333, W09359269, W10373038, W11376877, W11383061, X02383721, X03393461, X04396526, X05420178, and X07428874 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 16G, PPR67626, Lot Numbers: U0664915, V0440521, V06202413, V10272600, V11278907, W01288341, W01308058, W0140521, W02301157, W04314780, W11376884, X02388736, and X07420184 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5D, PPR67628, Lot Numbers: U0768644, U0778884, V03185938, V0431283, V09254656, V10281949, W01308060, W01308061, W01308062, W04306670, W09364719, W09374391, W10376707, and X0195958 TIGE "ANCA FIT(TM)" REV. HAP 1/3 PROXIMAL 17.5G, PPR67630, Lot Numbers: W01308064, W01308068, W0966209, and X02396549 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 9.5D (POLIE), PPR70000, Lot Number: X0543024110 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11D (POLIE), PPR70004, Lot Number: X04419060 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 11G (POLIE), PPR70006, Lot Number: X01388737 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12D (POLIE), PPR70008, Lot Number: X04419062 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 12G (POLIE), PPR70010, Lot Numbers: X01388721, X02396846, and X05428441 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13D (POLIE), PPR70012, Lot Numbers: V01121619, X05420170, and X09428857 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 13G (POLIE), PPR70014, Lot Numbers: W10373044, X0339651610, X04419065, X05420172, and X09428864 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14D (POLIE), PPR70016, Lot Number: X02388722 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 14G (POLIE), PPR70018, Lot Numbers: X04419067 and X05428442 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15D (POLIE), PPR70020, Lot Numbers: X01372772, X04419068, and X05420171 TIGE FEMORALE "ANCA FIT(TM)" A CIMENTER 15G (POLIE), PPR70022, Lot Numbers: X04401538, X04419069, and X05428444 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 17.5 LEFT, PPR72216, Lot Number: X03388712 STEM "ANCA FIT(TM)" COATED TP 1/3 PROXIMAL 16 RIGHT, PPR72234, Lot Number: X02388703 COTYLE "MULLER" A RETENTION 48*28, PPT01554, Lot Number: X05401328 COTYLE TYPE "MULLER" 44*28 , PPT02000, Lot Numbers: V09187401, W1182815, and X07401331 COTYLE TYPE "MULLER" 50*28 , PPT02300, Lot Number: X07401333 COTYLE TYPE "MULLER" 52*28 , PPT02302, Lot Numbers: X02402650 and X07401334 COTYLE TYPE "MULLER" 54*28 , PPT02400, Lot Number: X06396793 COTYLE TYPE "MULLER" 56*28 , PPT02402, Lot Number: X02402649 COTYLE TYPE "MULLER" 58*28 , PPT02500, Lot Number: X07401337 COTYLE TYPE "MULLER" 60*28 , PPT02501, Lot Number: X01388420 COTYLE TYPE "MULLER" 62*28 , PPT02502, Lot Number: X02402682 TETE FEMORALE 22 CM 12/14 CR/CO (0), PPT07032, Lot Numbers: W12376919, W12383538, X02391324, X04396795, X05396796, X05401639, X09419076, X09420351, X10428704, and X10428705 TETE FEMORALE 22 CL 12/14 CR/CO (+3.5), PPT07034, Lot Numbers: V06215393, W12383540, X01376920, X02391326, X02391327, X04396797, X05401340, X05419077, and X09419078 TETE A JUPE 22 CC 12/14 CR/CO (-3.5), PPT08110, Lot Number: X02383083 TETE A JUPE 22 CL 12/14 CR/CO (+3.5), PPT08114, Lot Number: X02383084 TETE FEMORALE 28 CM 14/16 CR/CO (0), PPT08600, Lot Number: X09440057 TETE FEMORALE 28 CL 14/16 CR/CO (+3.5), PPT08700, Lot Number: X09429157 TETE FEMORALE 28 CC 12/14 CR/CO (-3.5), PPT08710, Lot Numbers: U12116264, X01376909, X02391468, and X05411293 TETE FEMORALE 28 CM 12/14 CR/CO (0), PPT08712, Lot Numbers: X01391328 and X10440481 TETE FEMORALE 28 CL 12/14 CR/CO (+3.5), PPT08714, Lot Numbers: W01288441, X01376914, X01390673, and X05411373 TETE FEMORALE 28 EXL 12/14 CR/CO (+7), PPT08715, Lot Numbers: W10321555, X01383526, and X06391334 TETE FEMORALE 32 CC 14/16 CR/CO (-4), PPT09310, Lot Numbers: X01396350 and X02401177 TETE FEMORALE 32 CL 14/16 CR/CO (+4), PPT09312, Lot Numbers: X01391338, X0219810, X02401179, and X07401346 TETE FEMORALE 32 CC 12/14 CR/CO (-4), PPT09320, Lot Numbers: X01383527, X01391339, and X04396816 TETE FEMORALE 32 CM 12/14 CR/CO (0), PPT09322, Lot Numbers: X01383528, X01391340, and X04396768 TETE FEMORALE 32 CL 12/14 CR/CO (+4), PPT09324, Lot Numbers: X01391341 and X06396769 TETE FEMORALE 32 CC 12/14 CERAMIQUE AL2.O3, PPT10240, Lot Numbers: W12383531, W12395618, X01391483, X02403646, X05429126, X07435527, and X07440466 TETE FEMORALE 32 CM 12/14 CERAMIQUE AL2.O3, PPT10242, Lot Numbers: W12390616, W12395612, X01391484, X02403643, X03410193, X04419084, X05420339, X05426395, and X10445478 TETE FEMORALE 32 CL 12/14 CERAMIQUE AL2.O3, PPT10244, Lot Numbers: W11389001, W12383533, X01403644, X02396819, X02403645, X03410196, X04419085, X05426394, and X09429128 CUPULE MOBILE A BAGUE DE MAINTIEN D=40/22, PPT17000, Lot Numbers: X02383452 and X06421738 CUPULE MOBILE A BAGUE DE MAINTIEN D=43/22, PPT17003, Lot Numbers: V0397724 and X09420214 CUPULE MOBILE A BAGUE DE MAINTIEN D=45/28, PPT17005, Lot number: W05321489 CUPULE MOBILE A BAGUE DE MAINTIEN D=46/28, PPT17006, Lot Numbers: W02301213 and W04321170 CUPULE MOBILE A BAGUE DE MAINTIEN D=49/28, PPT17009, Lot Numbers: X02383457, X06401648, and X09419099 CUPULE MOBILE A BAGUE DE MAINTIEN D=51/28, PPT17011, Lot Numbers: X02383095 and X06419101 CUPULE MOBILE A BAGUE DE MAINTIEN D=52/28, PPT17012, Lot Numbers: X02383478, X03396733, X06401318, and X09419102 CUPULE MOBILE A BAGUE DE MAINTIEN D=53/28, PPT17013, Lot Numbers: X02396373 and X07410931 CUPULE MOBILE A BAGUE DE MAINTIEN D=54/28, PPT17014, Lot Numbers: W12376926, X02383458, X04396724, and X07401319 CUPULE MOBILE A BAGUE DE MAINTIEN D=55/28, PPT17015, Lot Numbers: X03373065, X04396725, X07419105, and X07420226 CUPULE MOBILE A BAGUE DE MAINTIEN D=56/28, PPT17016, Lot Numbers: X0197891A, X03396726, X03408880, X07419106, and X09420227 CUPULE MOBILE A BAGUE DE MAINTIEN D=57/28, PPT17017, Lot Numbers: X06410933 and X07420228 CUPULE MOBILE A BAGUE DE MAINTIEN D=58/28, PPT17018, Lot Numbers: W11344310 and X09420229 CUPULE MOBILE A BAGUE DE MAINTIEN D=59/28, PPT17019, Lot Numbers: X03383459 and X06396727 CUPULE MOBILE A BAGUE DE MAINTIEN D=60/28, PPT17020, Lot Numbers: W06335038, W12383096, and X07419109 VIS A COTYLE D5.5 L=15 "ANCA" , PPV20001, Lot Number: X08440222 VIS A COTYLE D5.5 L=20 "ANCA" , PPV20002, Lot Numbers: W12383687 and X08439698 VIS A COTYLE D5.5 L=25 "ANCA" , PPV20003, Lot Numbers: X01383688, X04401654, X07428902, and X08440224 SCREW FOR "ANCA" SHELL D = 5.5 MM L =30 MM, PPV20004, Lot Numbers: X07428903 and X08440225 VIS A COTYLE D5.5 L=35 "ANCA" , PPV20005, Lot Numbers: X0197339, X02388685, X07428904, and X08440226 VIS A COTYLE D5.5 L=40 "ANCA" , PPV20006, Lot Number: X01383691 VIS A COTYLE D5.5 L=45 "ANCA" , PPV20007, Lot Number: W0681431 VIS A COTYLE D5.5 L=50 "ANCA" , PPV20008, Lot Numbers: W0688950, W1046678, and W1096178 VIS A COTYLE D5.5 L=12 "ANCA" , PPV20010, Lot Numbers: X0435365 and X0440631 STEM REVISION "ULTIME" HA COATED 14/200 LOCKING SCREW D5, PPV80822, Lot Numbers: W01278970, W06309082, W10359026, X02378536, and X04383546 SCREW D5*30 TITANIUM "ULTIME" STEM REVISION, PPV80930, Lot Number: X01383581 SCREW D5*35 TITANIUM "ULTIME" STEM REVISION, PPV80935, Lot Number: X04411255 SCREW D5*40 TITANIUM "ULTIME" STEM REVISION, PPV80940, Lot Numbers: X04411893 and X06429125 SCREW D5*45 TITANIUM "ULTIME" STEM REVISION, PPV80945, Lot Number: X02391353 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00140, Lot Number: X04376678 PROFEMUR(R) STEM EXT 26MM X 21MM DIA, PPW00141, Lot Number: X04376679 PROFEMUR(R) STEM EXT 52MM X 19MM DIA, PPW00144, Lot Number: X04376681 PROFEMUR(R) STEM EXT 26MM X 19MM DIA, PPW00148, Lot Number: X03388493 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 10, PPW38000, Lot Numbers: U0465122, U0987554, X04401261, X04409719, X07418377, and X09420118 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 11, PPW38001, Lot Numbers: X03396422, X04401262, and X04409720 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 12, PPW38002, Lot Numbers: X03388501, X03396423, and X05409721 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 13, PPW38003, Lot Number: X03396424 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 14, PPW38004, Lot Numbers: X03388503, X03396425, X05401264, X05409723, and X07420122 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 15, PPW38005, Lot Numbers: X02388504, X02401703, X05409724, X07418382, and X10420123 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 16, PPW38006, Lot Numbers: X03396285, X03396427, and X06401265 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 17, PPW38007, Lot Number: X07418384 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 18, PPW38008, Lot Numbers: X05409725, X06401711, and X07418385 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 19, PPW38009, Lot Numbers: V11292269, X01401721, X02388505, X03396428, X05409726, X06401719, X06401722, and X07418386 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 20, PPW38010, Lot Numbers: W01300721, X04409727, X05100883, and X05401723 PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 21, PPW38011, Lot Numbers: V11290488, W12100884, X01401724, X01401726, X05409728, X06401728, and X07418387, PROFEMUR(R) 135MM STEM STRAIGHT/TAPER SIZE 22, PPW38012, Lot Numbers: X01401731, X05409729, X06100885, X06100885A, X06401729, and X07418388 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 10, PPW38020, Lot Numbers: X01383191, X02388517, X03396445, X05401266, and X05418389 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 11, PPW38021, Lot Numbers: X02388506, X04396437, X05409730, and X05418390 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 12, PPW38022, Lot Numbers: X01388507, X04409731, X05418391, and X07420124 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 13, PPW38023, Lot Numbers: X05418392 and X10428808 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 14, PPW38024, Lot Numbers: X01388421, X02388509, and X03396440 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 15, PPW38025, Lot Numbers: X02388510 and X03396441 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 16, PPW38026, Lot Numbers: X02388511, X05409733, and X05418395 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 17, PPW38027, Lot Numbers: X02388512, X03396442, and X05418396 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 18, PPW38028, Lot Numbers: X01383194, X02388513, X05409734, X05418397, and X07428418 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 19, PPW38029, Lot Numbers: V12277782, X01388514, X05409735, and X05418398 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 20, PPW38030, Lot Numbers: V12301619, W10372765, X03388515, X05418399, and X07428419 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 21, PPW38031, Lot Numbers: X05409736 and X05418400 PROFEMUR(R) 175MM STEM BOWED TAPER SIZE 22, PPW38032, Lot Numbers: X02388516, X03396443, X03409737, and X05418401 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 10, PPW38040, Lot Numbers: V10271407, W10376686, X01383196, X03396444, X04401258, X05409738, and X09418402 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 11, PPW38041, Lot Numbers: W01287432, X01388487, X03396446, and X06418403 PROFEMUR(R) 215MM STEM BOWED TAPER SIZE 12, PPW38042, Lot Numbers: X01388422, X02388488, and X04409739 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 13, PPW38043, Lot Numbers: X01383197, X02388489, and X06418405 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 14, PPW38044, Lot Numbers: X0284416, X03396449, and X05418406 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 15, PPW38045, Lot Numbers: V12292277, W02300946, X01382943, X01383198, X02388491, X05396450, X05401259, and X06418407 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 16, PPW38046, Lot Numbers: V06227308, W02301470, W11383199, X01388492, X01396451, and X06418408 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 17, PPW38047, Lot Numbers: V12287435, X03418617, X04401260, and X05418409 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 18, PPW38048, Lot Numbers: X03401750, X03401763, X04409743, and X06418410 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 19, PPW38049, Lot Numbers: V11292256 and X05418411 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 20, PPW38050, Lot Numbers: W01111358, X01401765, X03401767, X05418412, and X09420126 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 21, PPW38051, Lot Numbers: X06418413 and X0791110 PROFEMUR(R) 215MM STEM BOWED /TAPER SIZE 22, PPW38052, Lot Numbers: X01100887A, X0171384, X02397392, X03402993, X04418620, X05409744, and X07418414 "PROFEMUR(R) R" GRIT BLASTED PROX BODY XSMALL, PPW38058, Lot Numbers: V0171443, X03396492, X05401305, X05424421, and X08418416 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 1, PPW38061, Lot Numbers: X0795065.1 and W02112667 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3, PPW38063, Lot Numbers: W02110068 and W0375663 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4, PPW38064, Lot Number: W02110621 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 10.5, PPW38300, Lot Numbers: X04125745, X05409745, and X10420130 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 12, PPW38302, Lot Numbers: X05409746 and X09420131 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 13.5, PPW38304, Lot Numbers: X05396498, X05409747, and X09428420 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 15, PPW38306, Lot Numbers: V06227292, W12382947, W12383200, X03388494, X05100009X1, and X05396499 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 16.5, PPW38308, Lot Numbers: X05396500 and X09428421 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 18, PPW38310, Lot Number: W12382949 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 19.5, PPW38312, Lot Number: X09428422 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 21, PPW38314, Lot Number: X05409748 PROFEMUR(R) 135MM STRAIGHT CYL PS SIZE 22.5, PPW38316, Lot Numbers: X04125877, X05409749, and X09420132 PROFEMUR(R) 175MM BOWED CYL PS SIZE 10.5, PPW38320, Lot Number: X05409750 PROFEMUR(R) 175MM BOWED CYL PS SIZE 12, PPW38322, Lot Numbers: X03396290, X05396501, and X05409751 PROFEMUR(R) 175MM BOWED CYL PS SIZE 13.5, PPW38324, Lot Numbers: W01300737, X04396502, and X05102041 PROFEMUR(R) 175MM BOWED CYL PS SIZE 15, PPW38326, Lot Numbers: X03396291 and X05396503 PROFEMUR(R) 175MM BOWED CYL PS SIZE 16.5, PPW38328, Lot Numbers: X03396292, X10396504, and X10439998 PROFEMUR(R) 175MM BOWED CYL PS SIZE 18, PPW38330, Lot Numbers: X03382950, X03396293, and X05409752 PROFEMUR(R) 175MM BOWED CYL PS SIZE 19.5, PPW38332, Lot Numbers: X05409753 and X10428423 PROFEMUR(R) 175MM BOWED CYL PS SIZE 21, PPW38334, Lot Numbers: X05409754 and X10428424 PROFEMUR(R) 175MM BOWED CYL PS SIZE 22.5, PPW38336, Lot Numbers: V07100720, X05121256, X05409755, and X10420134 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY X-SMALL MODULAR, PPW38354, Lot number: X09401306 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY SMALL, PPW38360, Lot Number: U1078950 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 1, PPW38361, Lot Number: W12382952 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 2, PPW38362, Lot Numbers: X04396506 and X09401251 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 3, PPW38363, Lot Numbers: X02382954, X04396507, and X08409756 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY STD 4, PPW38364, Lot Numbers: W12382955, X02383204, X02385735, and X05409757 "PROFEMUR(R) R" PROX BODY PLASMA SPRAY LARGE, PPW38365, Lot Number: X05409758 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ10.5, PPW38370, Lot Numbers: U0463053, W01100739, X03396294, and X05409759 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 12, PPW38372, Lot Numbers: X03396295 and X05409760 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 15, PPW38376, Lot Number: X03396297 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ16.5, PPW38378, Lot Numbers: X05409761 and X09428425 PROFEMUR(R) 115MM STRAIGHT FULLY COATED CYL/PS SZ 18, PPW38380, Lot Numbers: X05409762 and X09428426 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ19.5, PPW38382, Lot Numbers: X04125896, X05409763, and X10428427 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ 21, PPW38384, Lot Numbers: X05125897, X05409764, and X10420141 PROFEMUR(R) 115MM STRAIGHT FULLY COATD CYL/PS SZ22.5, PPW38386, Lot Numbers: X05409765 and X10428428 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SZ 12, PPW38404, Lot Number: X04100973 PROFEMUR(R) 95MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38410, Lot Number: X0239629910 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38422, Lot Number: X04409768 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 12, PPW38424, Lot Numbers: W01300738, X04100971, and X04100978 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 16.5, PPW38430, Lot Numbers: X05100968 and X05409769 PROFEMUR(R) 115MM STRAIGHT CYL SPLINE SIZE 18, PPW38432, Lot Number: X05409770 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 10.5, PPW38442, Lot Number: X05410188 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 15, PPW38448, Lot Numbers: X02396302 and X04409773 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 18, PPW38452, Lot Number: X04409774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 19.5, PPW38454, Lot Numbers: X04129583 and X04409775 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 21, PPW38456, Lot Numbers: X04129255, X04409776, and X05425774 PROFEMUR(R) 135MM STRAIGHT CYL SPLINE SIZE 22.5, PPW38458, Lot Number: X04129256 TIGE PROXIM. MONOBLOC V4 EV1 "PROFEMUR(R) R" EX/SMALL, PPW39009, Lot Numbers: U01136593, U0665166, X08401542, and X09419124 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 2 V4, PPW39106, Lot Number : X05401544 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 3 V4, PPW39108, Lot Numbers: W06328345, X02388522, X05409779, and X09419155 "PROFEMUR(R) R" GRIT BLASTED PROX BODY STD 4 V4, PPW39110, Lot Numbers: X01385799, X02388523, X03396485, X05401545, and X05409780 "PROFEMUR(R) R" GRIT BLASTED PROX BODY LARGE V4, PPW39112, Lot Numbers: X01383506, X02388524, X04396486, X05401546, and X08409782 "PROFEMUR(R) R" HA COATED PROX BODY SMALL V4, PPW39122, Lot Number: U0980429 "PROFEMUR(R) R" HA COATED PROX BODY STD 1 V4, PPW39124, Lot Number: V11244233 "PROFEMUR(R) R" HA COATED PROX BODY STD 2 V4, PPW39126, Lot Numbers: U1187740 and V11244234 "PROFEMUR(R) R" HA COATED PROX BODY STD 3 V4, PPW39128, Lot Numbers: V05143958, X04396496, and X09419148 "PROFEMUR(R) R" HA COATED PROX BODY STD 4 V4, PPW39130, Lot Numbers: U1180433, V02140197, W11359374, X04396497, X07401247, X09419149, and X09428831 "PROFEMUR(R) R" HA COATED PROX BODY LARGE V4, PPW39132, Lot Numbers: W01278887, W06314895, W07328343, X07401248, and X09419150 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 00, PPX028059, Lot Number: X01350955 FEMORAL STEM "HELIANTHE" COATED HAP SIZE 5, PPX028065, Lot Number: X02388557 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 3, PPX02873, Lot Numbers: X04404311 and X06420279 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 4, PPX02874, Lot Numbers: X03396831 and X05419133 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 5, PPX02875, Lot Numbers: X02383116, X02396342, and X03396832 FEMORAL STEM POLISHED CEMENTED "HELIANTHE" SIZE 6, PPX02876, Lot Numbers: X04388553 and X04396833 Class II There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. Wright Medical Technology Inc
Devices Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBIAL PE IB II-69 12.5, PPB30164, Lot Numbers: V10278847 and W11386265 PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929 PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239 ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229 ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499 CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773 CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523 1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070 1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693 CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706 Orthopaedic ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBIAL PE IB II-69 12.5, PPB30164, Lot Numbers: V10278847 and W11386265 PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929 PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239 ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229 ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499 CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773 CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523 1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070 1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693 CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706 Class II There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. Wright Medical Technology Inc
Devices Extremity Components: PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Orthopaedic PROTHESE A EXPANSION COMPLETE D=6 LG 12 MM, Part Number PPO90000, Lot Numbers: U11113596, W12372884, W12376849, X01383482, X06391313, X07401148, X07401445, and X09418985 PROTHESE A EXPANSION COMPLETE D=8 LG 15 MM, Part Number PPO90100, Lot Number X09418986 PROTHESE A EXPANSION COMPLETE D=10 LG 18 MM, Part Number PPO90200, Lot Numbers: X06391315, X07401150, X07420387, and X09401447 PROTHESE A EXPANSION COMPLETE D=12 LG 20 MM, Part Number PPO90300, Lot Numbers: W12383045, W12383485, X06391316, X06396622, X07401448, and X09418988 TIGE HUMERALE PROXIMALE "NGR" LONG, Part Number PPP70088, Lot Number X01359005 Class II There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility. Wright Medical Technology Inc
Devices Safe Spot Infant Resuscitator, SS3200 Series, Single Patient Use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Codes: SS3200MB, Lot #10030, 100251, 100381, 100432, 100656, 100791, 101101, 10131; SS3200MB-2, Lot #100131; SS3200MB-1, Lot #101238, 101370, 101480, 101820, 102009; SS3200MB-MMC, Lot #100129; SS3200MBP-2, Lot #102057; SS3200MBP-M00, Lot #100132, 101462, 102051; SS3200OB, Lot #100133, 100252, 100979, 101178, 101863, 101975 and SS3200OB-PW, Lot #100134, 100253. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Adult Resuscitator, Pro-5000 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Code: PRO-5009P, Lot #102217. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Stat-Check Resuscitator, Adult Manual Emergency Resuscitator with A.C.E. /Stat-Check CO2 Indicator, SC 9000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Codes: SC9001C, Lot #101360, 101751, 101819, 101948, 102090, 102164 and SC9001C-C, Lot #101100, 101441, 101780, 102193. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices V*Care Resuscitator Infant Resuscitator, VN 3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Codes: VN3200MB, Lot #102032, VN3100MB-2, Lot #102033; VN3100MBP, Lot #102046, 102182; VN3100MB-PW2, Lot 3102050; VN3100OB, Lot #102150. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Code: Product List 071012, Product Codes: BT2200FK, Lot #100196, BT2216, Lot #100138, BT2216F, Lot #100139, BT2216K, Lot #100197, BT2220, Lot #100140, BT2220, Lot #100141, BT2416, Lot #100142, BT2416F, Lot #100143, BT2416K, Lot #100198, BT2420, Lot #100144, BT2420F, Lot #100145 and BT2420FK, Lot #101081. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices AirFlow Resuscitator, Adult Resuscitator, AF1000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Code: AF1040MB, Lot #102091 and 102191; AF1040MBP, Lot #102106 and 102174; AF1040MBS, Lot #102189, AF1040MB-S5, Lot #102105, AF1040MB-T, Lot #101917 and 102151; AF1100MB, Lot #102227, AF1140MB, Lot #102081 and 102139, AF1140MB-K, Lot #102093 and 102165; AF1140MB-P5, Lot #102145; AF1140MBP-T, Lot #102096 and Product Code: AF1140MB-T, Lot #101666. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Safe Spot Infant Resuscitator, Pro-1900 Series, Single Patient Use, The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product List 071012, Product Codes: PRO-1904, Lot #100155, 100183, 100451, 100497, 100655, 101577 and PRO-1925, Lot #101550, 101604101657. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Ventlab Premium Small Child Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. Product Code: VN4100OB, Lot #102015. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Ventlab Premium Small Adult Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product Code: VN500MX, Lot #102194. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices Ventlab Rescue Med Infant Resuscitator, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028. The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product Code: BVM700, Lot #101638. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices AirFlow, Infant Resuscitator, AF3000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product Code: AF3100MB-M1, Lot #102185; AF3140MB-I, Lot #102129 and AF3140MB-K, Lot #101592, 101729 &102130. Recall was amended to include the following: Product Code: AF3040MB, Lot#101450 &101634; AF3040MB-K, Lot #101728; AF3100MB, Lot #101562, 101687 & 102120; AF3100MB-M01, Lot #102121; AF3100MB-M1, Lot #101285, 102122 & 102185; AF3100MBP, Lot #101264 & 101437; AF3140MB, Lot #101154, 101306, 101661, 102126, 102168; AF310MB-2, Lot #101222 & 102127; AF3140MB-D1, Lot #101223, 101303, 101386 &102128; AF3140MB-D12I, Lot #101368; AF3140MB-I, Lot #101451; AF3140MB-M1, Lot #101730; AF3140MB-P, Lot #101266, 101366, 101614 & 102132 and AF3140OB, Lot #101156 &102134. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest. Product Code: AF5140MBPWTD5, Lot #101806 and 102163; AF5140MB-T, Lot #102075 and AFD5140MB-T, Lot #101928 &102211. Recall was amended to include the following: AF5140MBS-I, Lot #101898; AF5140MB-ST, Lot #101896; AF5140MBS, Lot #101900 and AF5140MBS-R, Lot #101899. Class I Possible volume leakage through the inlet valve during compressions of the resuscitator bag. Ventlab Corporation
Devices SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less. Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction. Sorin Group USA, Inc.
Devices SCP Pump Control Panel, Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolution pump head for speed-controlled pumping through cardiopulmonary bypass circuit for typical durations of six hours or less. Product Code: 60-02-50, Serial Numbers: 60S09131, 60S09133-60S09135, 60S09140-60S09142, 60S08954. Class II Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel . An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after the malfunction. Sorin Group USA, Inc.
Devices ILLlCO® MIS Posterior Fixation System, Bone-screw Internal Spinal Fixation System, Orthosis, Spinal Pedical Fixation Orthosis, Spondylolisthesis Spinal Fixation The ILLICO MIS Posterior Fixation System is intended to facilitate the surgical correction of noncervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. When used for a minimally invasive posterior approach ILLlCO® MIS Instrumentation is used in conjunction with polyaxial screw components. The ILLICO MIS Posterior Fixation System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies of the spine. It is intended to provide stabilization during the development of fusion utilizing a bone graft. Specific indications for the ILLICO MIS Posterior Fixation System are dependent in part on the configuration of the assembled device and the method of attachment to the spine. Product Codes: KW, MNI, MNH. Part NumberlLot Number: ’PART DESCRIPTION LOT 7384S-30 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 30mm 646501 73845-35 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 35mm 646502 73845-40 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 40mm 646503 73845-45 Ti CANNULATED POLYAXIAL SCREW 4.5mm X 45mm 646504 73855-35 Ti CANNULATED POLYAXIAL SCREW 5.5mm X 35mm 646510 73865-30 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 30mm 646515 73865-35 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 35mm 646516 73865-40 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 40mm 646517 73865-45 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 45mm 646542 73865-50 Ti CANNULATED POLYAXIAL SCREW 6.5mm X 50mm 646543 73875-35 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 35mm 646546 73875-45 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 45mm 646548 73875-50 Ti CANNULATED POLYAXIAL SCREW 7.5mm X 50mm 646549 Class II The firm initiated the recall because the stainless steel guide-wire of the Illico MIS Fixation System did not completely fit/pass through the tip of certain Illico Ti Cannulated Polyaxial Screws, therefore rendering such screws nonfunctional. Alphatec Spine, Inc.
Devices West Nile Virus IgG DxSelect" kit Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. 510(k) No. K031953 The Focus Diagnostics West Nile Virus ELISA IgG is intended for qualitatively detecting IgG antibodies to West Nile virus in human serum. In conjunction with the Focus Diagnostics West Nile Virus IgM Capture ELISA, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Catalog No. EL0300G Kit Lots 122150, 122155, 122641, 122650 and 122859 that includes West Nile Virus IgG Antigen Wells, Catalog Number EL0351, Lot Number 121117. Class III The firm recalled due to higher reactivity with some samples in the effected lots, which may reflect a higher false positive rate. Focus Diagnostics Inc
Devices ARIA Radiation Oncology, Version 11. Varian Medical Systems, Palo Alto, CA. The ARIA Radiation Oncology product is a treatment plan and image management application. Model number: HIT Serial numbers: HIT0027 HIT1430R3 HIT2208R3 HIT3513 HIT2546 HIT2546 HIT2546 HIT0028 HIT1470M HIT2208R4 HIT3679 HIT2591 HIT2591 HIT2591 HIT0032 HIT1470R1 HIT2208R5 HIT3910 HIT2615 HIT2615 HIT2615 HIT0134 HIT1470R2 HIT2212 HIT3927M HIT2643 HIT2643 HIT2643 HIT0155 HIT1523M HIT2237M HIT3927R1 HIT2645 HIT2645 HIT2645 HIT0170M H1T1523R1 HIT2237R1 HIT3927R2 HIT2834 HIT2834 HIT2834 HIT0170R1 HIT1587M HIT2267M HIT3967 HIT2865 HIT2865 HIT2865 HIT0170R2 HIT1587R1 HIT2267R1 HIT4014 HIT2894M HIT2894M HIT2894M HIT0170R3 HIT1587R2 HIT2275M HIT4116 HIT2894R1 HIT2894R1 HIT2894R1 HIT0182 HIT1587R3 HIT2275R1 HIT4118M HIT2894R2 HIT2894R2 HIT2894R2 HIT0183 HIT1587R4 HIT2275R2 HIT4118R1 HIT2894R3 HIT2894R3 HIT2894R3 HIT0191M HIT1589M HIT2275R3 HIT4381 HIT2943 HIT2943 HIT2943 HIT0191R1 HITI589R2 HIT2275R4 HIT4555 HIT2953 HIT2953 HIT2953 HIT0191R2 HITI589R3 HIT2291M HIT4592 HIT2997 HIT2997 HIT2997 HIT0227 HIT1589R4 HIT2291R1 HIT4627 HIT3088M HIT3088M HIT3088M HIT0339M HIT1589R5 HIT2291R2 HIT4861 HIT3088R1 HIT3088R1 HIT3088R1 H1T0339R1 HIT1589R6 HIT2291R3 HIT4884 HIT3088R2 HIT3088R2 HIT3088R2 HIT0342 HIT1589R7 HIT2291R4 HIT4888M HIT3088R3 HIT3088R3 HIT3088R3 HIT0397 HIT1589R8 HIT2291R5 HIT4888R1 HIT3088R4 HIT3088R4 HIT3088R4 HIT0432M HIT1589R9 HIT2291R6 HIT4888R2 HIT3088R5 HIT3088R5 HIT3088R5 HIT0432R1 HIT1660M HIT2293 HIT4888R3 HIT3088R6 HIT3088R6 HIT3088R6 HIT0432R2 HIT1660R2 HIT2346M HIT4894 HIT3097 HIT3097 HIT3097 HIT0468M HIT1660R3 HIT2346R1 HIT4896 HIT3165 HIT3165 HIT3165 HIT0468R1 HIT1671 H1T2425 HIT4903 HIT3206 HIT3206 HIT3206 HIT0535 HIT1693 HIT2441 HIT4906 HIT3267 HIT3267 HIT3267 HIT0551 HIT1726 HIT2477M HIT4932M HIT1800 HIT2522 HIT0632M HIT1753 HIT2477R1 HIT4932R1 HIT0632R1 HIT1757 HIT2477R2 HIT4947 HIT0632R2 HIT1767M HIT2477R3 HIT4974 HIT0668 HIT1767R1 HIT2512M HIT4982 HIT0691M HIT1780 HIT2512R1 HIT5061 HIT0691R1 HIT2208R2 HIT3268 HIT0691R2. Class II An anomaly has been identified with the ARIA Oncology Information System Version 11 where Monitor Units of one fraction may be incorrect, when partial treatment is being continued. Varian Medical Systems, Inc. Oncology Systems

WEEK ENDING NOVEMBER 3

Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices GE Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1 Seno Advantage 1.x, Seno Advantage 2.0, Seno Advantage 2.1: Seno Advantage is a medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. When interpreted by a trained physician, mammographic images displayed on the high-resolution monitors may be used as an element for diagnosis. Furthermore filmed images from all modalities may also be used as an element for diagnosis. Mfg Lot or Serial # SA2 000000410032GS 000000410033GS 000000410027GS 000000410047GS 000000410041GS 000000410051GS 000000410087GS 000000410065GS 000000410031GS 000000410035GS 000000410136GS 000000410064GS 000000410037GS 000000410030GS 000000410049GS 000000410028GS 000000410113GS 000000410069GS 000000410052GS 000000410056GS 000000410043GS 000000410044GS 000000410048GS 000000410038GS 000000410042GS 000000410101GS 000000410036GS 000000410039GS 000000410073GS 000000410054GS 000000410134GS 000000410062GS 000000410112GS 000000410045GS 000000410063GS 000000410060GS 000000410034GS 000000410072GS 000000410057GS 000000410061GS 000000410058GS 000000410050GS 000000410071GS 000000410059GS 000000410055GS 000000410070GS 000000410053GS 000000410029GS 000000410067GS 000000410068GS 000000410066GS 000000410133GS 000000410011GS 000000410010GS 000000410009GS 000000410007GS 000000410006GS 000000410008GS 000000410096GS 000000410089GS 000000410090GS 000000410088GS 000000410086GS 000000410001GS 000000410046GS 000000410040GS 000000410014GS 000000410013GS 000000410015GS 000000410012GS 000000410022GS 00000L0265F2Fe 000000410016GS 000000410018GS 00000L02746AAA 000000410005GS 000000410019GS 000000410017GS 000000410023GS 000000410024GS 00000L0215A2F7 000000410020GS 000000410021GS 000000410109GS 000000410104GS 000000410103GS 000000410105GS 000000410106GS 000000410107GS 000000410102GS 000000410119GS 000000410108GS 000000410091GS 000000410098GS 000000410100GS 000000410082GS 000000410135GS 000000410078GS 000000410079GS 000000410085GS 000000410081GS 000000410080GS 000000410093GS 000000410094GS 000000410083GS 000000410084GS 000000410077GS 000000410076GS 000000410075GS 00000L028421B6 000000410124GS 000000410127GS 000000410120GS 000000410125GS 000000410131GS 000000410132GS 000000410123GS 000000410122GS 000000410126GS 000000410121GS 000000410128GS 000000410130GS 000000410129GS 000000410025GS 00000L021564F6 000000410092GS 000000410074GS 000000410117GS 000000410099GS 000000410114GS 000000410026GS 000000410111GS 00000L02A95ABE 000000410115GS 000000410116GS 000000410118GS 000000410002GS 000000410110GS 000000410097GS 000000410095GS 000000410138GS 000000410004GS 000000410003GS 000000410137GS FMI# 12129_SA1.x Mfg Lot or Serial # 00000L0238B0F6 00000L02AB16F5 00000L02227D84 00000L0221EDA2 00000LEE1BC987 00000LEE1F8870 00000L0235C516 00000L020136EE 00000L02510750 00000L027207CA 00000L02700093 00000LEE1F8744 00000L02227BAC 00000L02373AF4 00000LEE1F849C 00000L0265F748 00000LEE1F83BF 00000L0236BA7C 00000L023825D4 00000L025FB4AA 00000L0238B098 00000L025B5665 00000L025B53AF 00000L0265F50E 00000L0265FAC2 00000L0265F6AB 00000LEE1F85D1 00000L025B539D 00000L0235B91A 00000LEE1F8616 00000L0265F995 00000L025D689A 00000L0235C7DA 00000LEE1F8747 00000L0265F547 00000L0235B8DA 00000L02227CC2 00000L0235C642 00000LEE1F8896 00000L02227DF4 00000L023A0BBE 00000L025B53A8 00000L025B53A5 00000L02068226 Class II GE Healthcare has become aware of an issue associated with the magnification images acquired on non-GE digital mammography systems and your Seno Advantage Workstation that may impact patient safety. The measurement values provided by the Seno Advantage Workstation may be incorrect when applied to magnification images acquired on non-GE digital mammography systems. If not noticed by the caregiver, this could lead to an overestimate of the size of the breast lesion. The measurement values for GE images are not affected. GE Healthcare, LLC
Devices GE Healthcare, Seno Advantage 2.2 workstations with software version 22_01 and 22_02 A medical image review station that allows easy selection, processing, filming and media interchange of multi-modality images from a variety of diagnosis imaging systems. 000000010005GS 000000010004GS 000000010009GS 000000010007GS 000000010006GS 000000010010GS 000000010001GS 000000010002GS 000000010008GS 000000010003GS 00000L3A4391A7 00000L3A8D5CF0 Class II GE Healthcare has recently become aware of inaccurate Scale factor annotation provided by SenoAdvantage 2.2 workstations that may impact patient safety. This issue may result in a potential miscalculation of size. GE Healthcare, LLC
Devices Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16400 and serial numbers: 1001-1141, 1143-1274, and 1333. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16401 and serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16405 and serial numbers: 1001-1466 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16406 and serial numbers: 1001-1004, 1007-1055, 1057-1310, 1648, 1649, 1657, 1822, and 1823. Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16409 and serial numbers: 1001-1026 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporation
Devices Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Catalog number: 16410 and serial numbers: 1001-1034, 1036-1622 Class II Terumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the power distribution and battery back-up systems for the Sarns Modular Perfusion System 8000. Very few of the reports occurred during cardiopulmonary bypass; the majority of the malfunctions occurred during set-up or were reported during routine preventative maintenance. The malfunctions can be broadly categorized as loss of wall (AC) power, battery back-up malfunction and battery status indicator malfunction. In one category of malfunction, the Operator's Manual for the Sarns System 8000 does not provide sufficient instruction: how to respond to a flashing red indicator light. As a result, Terumo CVS is informing Sarns System 8000 users of the risks associated with these malfunctions and providing an addendum to inform the user how to respond to a blinking red battery status indicator. There are no known reports of patient injury as a result of these issues. Terumo Cardiovascular Systems Corporatio
Devices Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16026-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural List Number 16026-01, all serial numbers Class I The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. Hospira Inc.
Devices Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; List Number 16027-01 Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural List Number 16027-01, all serial numbers Class I The Symbiq pump touchscreen may not respond to user selection, may experience a delayed response, or may register a different value from the value selected by the user. Failure of the touchscreen to respond to user input could result in a delay in therapy or result in over delivery or under delivery of medication if the user does not confirm the programmed values on the pump's confirmation screen prior to starting the infusion. Hospira Inc.
Devices "****ORTHO SENSOR**12-123-A Knee Trial for Trithion***1560 Saw grass Corporate Pkwy***4Th floor***Sunrise, FL 33323***

www.orthosensor.com***" Rx Only*** Sterile/EO***Made exclusively for Stryker Orthopaedics***. Is the graphic user interface software associated with the graphic user interface, which is loaded onto the linkstations.

Version 1.82 Class II Ortho sensor in Sunrise, FL is recalling the Graphics User Interface Software 1.8 (which was updated to version 1.82, validated on 02/13/12). Recall was initiated due to customer feedback which included the line of site between the knee ba lancer and the Link station was obstructed by OR metal stands or trays or the knee balancer device was placed atop of or near the metal stands or trays, interruption in the RF communications would occur momentarily. Orthosensor
Devices SpiraLok 5.0mm with Ethibond and needles Product Number: 222960 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0mm with Panacryl and needles Product Number: 222961 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5mm with Panacryl and needles Product Number: 222963 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0mm with Ethibond without needles Product Number: 222964 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices Screw, fixation, boneProduct Number: 222967 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0 w/Needles with Orthocord Product Number: 222968 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0 w/out Needles with Orthocord Product Number: 222969 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5 w/Needles with Orthocord Product Number: 222970 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5 w/out Needles with Orthocord Product Number: 222971 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0 w/Needles with violet and blue Orthocord Product Number: 222985 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5 w/Needles with violet and blue Orthocord Product Number: 222987 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices SpiraLok 6.5 w/out Needles with violet and blue Orthocord Product Number: 222988 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow All lot codes Class II Fracture of SPIRALOK Anchors post op, requiring patient revision DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number 442600. The SYNCHRON MULTI-CALIBRATOR, used in conjunction with SYNCHRON reagents, is intended for use on SYNCHRON Systems for the calibration of Albumin, Blood Urea Nitrogen (Urea), Calcium, Cholesterol, Glucose, Inorganic Phosphorus, Lactate,Magnesium, Total Protein, Triglycerides, and Uric Acid. Lot M002642 Class III The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron Systems Multi Calibrator Diskettes (REF 442600, lot M002642G) may actually be Thyroxine (T4) Reagent Calibrator Diskettes. Beckman Coulter Inc.
Devices UniCel® DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel® DxC Synchron® Clinical Systems are fully automated, computercontrolled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Part Number B12218. Serial numbers 2329, 5477, 5479. Class II Beckman Coulter has confirmed that the Shuttle to Barcode Reader and Cap Piercer alignment procedure cannot be performed on certain DxC configurations with v5.0.11 software installed. If the Shuttle to Barcode Reader becomes misaligned, the Operator will not be able to perform this alignment procedure on the DxC systems listed above. Software v5.0 .11 does not allow access to the Shuttle to Barcode Reader and Cap Piercer alignment procedure on systems with no Cap Piercer. Currently, there are no means for restoring instrument functionality using software v5.0.11 if the shuttle becomes misaligned. As a result, there is a potential for a delay in reporting patient results. Beckman Coulter Inc.
Devices AdvanDx E. coli/P. aeruginosa PNA FISH, In Vitro Diagnostic Culture Identification Kit for Escherichia coli and Pseudomonas aeruginosa Catalog Number : KT007 Usage: E. coli/P. aeruginosa PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for identification of Escherichia coli and Pseudomonas aeruginosa on smears of positive blood cultures containing Gram-negative rods. The E.coli/P. aeruginosa PNA FISH assay is indicated for use as an aid in the diagnosis of E. coli and/or P. aeruginosa bacteremia. Lot Numbers: 01812A-US, 03412A-US and 00512A-EU Exp Date: 12-2013 Class II Some strains of Pseudomonas putida cross-react with the P. aeruginosa PNA probe used in E. coli/P. aeruginosa PNA FISH (KT007) due to a sequence similarity resulting in a cross-reaction that may produce a red-positive signal Advandx Inc
Devices Reference materials "RETINAL OCT Analysis and Interpretation Method" shipped with iVue System (K091404) and the "Retina Poster" shipped with iVue System (K091404) and RTVue Systems (K101505); Models: iVue-100, RTVue-100; The physical Product is manufactured and distributed by Optovue, Inc. Fremont, CA The product is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. All units of these models. Class II Devices labeled for an intended use not included in the existing 510(k) or PMA. Specifically, "The Retina" poster provided with the systems, and the book "RETINAL OCT Analysis and Interpretation Method" by Bruno Lumbroso and Marco Rispoli which are not labeled within 51O(k) cleared product description. Optovue Inc.
Devices AdvanDx GNR Traffic Light PNA FISH, In Vitro Diagnostic for Culture Identification Kit for Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa Catalog number: KT011. GNR Traffic Light PNA FISH is a multicolor, qualitative nucleic acid hybridization assay intended for the identification of Escherichia coli,and/or Klebsiella pneumoniae and/or Pseudomonas aeruginosa on smears from positive blood cultures containing Gram-negative rods observed on Gram stain. Sub-culturing of positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth. The GNR Traffic Light PNA FISH assay is indicated for use as an aid in the diagnosis of coli, and/or K. pneumoniae, and/or P. aeruginosa bacteremia. Lot Numbers: 02012A-US Exp. Date: 4-2014; 0812A-US Exp. Date: 12-2013; 01212A-EU Exp. Date: 4-2012 00712A-EU Exp. Date: 12-2013 Class II GNR Traffic Light PNA Fish may have false positive results with Pseudomonas putida and Pseudomonas fulva Advandx Inc
Devices EVICEL Fibrin Sealant (Human) Rx Only. Manufacturer: Omrix Biopharmaceuticals Ltd. MDA blood bank, Sheba Hospital, Ramat-Gan, POB 888, Kiryat Ono 55000 Israel U.S. License No. 1603. Distributed by: Ethicon, Inc. P.O. Box 151, Somerville, NJ 08876-0151 USA. The Pressure Regulator System is positioned on the floor or on an IV pole and accepts medical gas (compressed air, nitrogen, CO2) from the central hospital system or from medical gas cylinders. To include all lots and product codes for EVICEL and Omrix pressure regulators. Class II Ethicon and Omrix Biopharmaceuticals have received reports of air or gas embolism occurring in association with the use of spray devices employing a pressure regulator to administer EVICEL; these events appear to be related to the use of the spray device at higher-than-recommended pressures and/or in close proximity to the tissue surface. The field correction initiated is to provide the recommend pressure range to be used in the spray application of EVICEL and to communicate the Risk of air/has embolisms when the product is incorrectly applied. Ethicon, Inc.
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, w/Crickett 25g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot# 38592, 38992, 39210, 39743, 39886, 40627, 40953, 41121, 41560, 41882, 43504, 43619, 45251, 45827, 45919, 46657, 47598, Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3165-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. not available Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073, Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with Eclipse, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 48072 Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3342-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Part Number: 3342-95, Lot Numbers: 39212, 38783, 40566, 40636, 40865, 41823, 42380, 43753, 45317, 46270, 46355, 47310, 49450, 49716. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 38637, 38915, 39143, 39147, 39146, 39392, 39745, 39746, 39747, 39748, 40014, 40226, 40225, 40224, 40223, 40565, 40910, 40567, 40955, 41086, 41087, 41317, 41413, 41412, 41414, 41592, 41973, 42071, 42171, 42321, 42595, 42319, 43180, 43130, 43405,43618, 43751, 44064, 44104, 44145, 44384, 44566, 44835, 45057, 45058, 45257, 45255, 45256, 45366, 45669, 45766, 45882, 46108, 46108, 46122, 46339, 46469, 46777, 46655, 46974, 47080, 47226, 47314, 47434, 47596, 47651, 47747, 47746, 48157, 48221, 48483, 48579, 48507, 48623, 48622, 48482, 48762, 48810, 48971, 48927, 49096, 49182, 49259, 49301, 49304, 49303, 49305, 49451, 49586, 49786, 49842. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1", 25U Balanced Heparin, part number: 3362-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 39560, 39833, 40185, 40201, 40332, 40983, 41027, 41253, 41693, 41884, 42224, 42592, 42977, 43290, 43373, 43564, 43670, 43752, 44143, 44333, 44677, 44752, 45212, 45559, 45560, 45699, 46107, 46356, 46271, 46654, 46923, 47078, 47218, 47774, 48288, 48143. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, Luer Slip Barrel, 25U Balanced Heparin, No B Needle or Q-Cork, part number: 3363-95S. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 43406, 43607, 44030, 44062, 44264, 44327, 44422, 44863, 44981, 45262, 46124, 46886, 46585, 47077, 47312, 48831. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g x 1" A/B Needle, 25U Balanced Heparin, part number: 3372. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 38941, 39213, 40203, 41694, 42317, 42700, 43129, 43195, 43502, 44695, 45065, 45254, 45919, 46776, 47369, 4669149785. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 22g x 1" A Needle, 25U Balanced Heparin, part number: 3372-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 38747, 40202, 40423, 40728, 41028, 43127, 44144, 44383, 44648, 44862, 45253, 45825, 46357, 46775, 47079, 47607, 47773, 47733, 48350, 48220, 48809, 48894, 49035, 49095, 49181, 49256, 49326, 49356, 49568, 49717, 49905, 50935. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A/B Needle, 25U Balanced Heparin, part numbers: 3373, 3393. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Part Number 3373, Lot Numbers: 38813, 38634, 39148, 39946, 40951, 40952, 41593, 41740, 42914, 43291, 43999, 45252, 46341, 46653, 47175, 47371, 48029, 48266, 48351, 48495, 48661, 48897, 49145, 49236, 49325, 49408, 49522, 49718, 49966. Part Number: 3393, Lot numbers: 38995, 33994, 39788, 40082, 40568, 40569, 40674, 40994, 41325, 41326, 41749, 41931, 44536, 44534, 44535, 44533. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3373-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 38784, 39142, 39144, 39145, 39211, 39137, 39141, 39322, 39321, 39629, 39628, 39630, 39830, 39831, 39832, 40424, 40625, 40950, 41402, 41415, 42070, 42416, 42517, 42858, 43325, 43196, 43577, 43982, 44146, 44678, 45562, 45671, 45826, 46340, 46470, 46780, 46779, 47081, 47174, 47370,47487, 47597, 47606, 47847, 48484, 48580, 48625, 48811, 48860, 48896, 49036, 49260, 49357, 49473, 49569, 49906. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1" A Needle w/Eclipse, 25U Balanced Heparin, No CE, part number: 3373-98. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Lot Numbers: 47652, 48352. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, w/Crickett 23g x 1" A Needle, 25U Balanced Heparin, part number: 3383-95, 3344-95, 3353-95. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. Part Number: 3383-95, Lot Numbers: 43895, 45117, 47953, 48895. Part Number: 3344-95, Lot Numbers: 33814, 39481, 39786, 40083, 40333, 41338, 41642, 41885, 42318, 43129, 43606, 44063, 45116, 45765, 45898, 46358, 46905, 47313, 47595, 48153, 48155, 48154, 48156, 48348, 48624, 49000, 49097, 49100, 49099, 49098, 49102, 49101, 49257, 49841. Part Number: 3353-95, Lot Numbers: 40981, 42106, 45561, 48288, 49258. Class II Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants. Westmed Inc
Devices DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpiece Catalog Number: 227305 The DePuy Mitek VAPR Electrodes for use with the VAPR Radiofrequency System are intended for resection, ablation, excision, hemostasis of blood vessels, and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and/or wrist. Lot Number: M1108086 Class II Product may have wrong large product identification label with symbols on the box indicating a S90 VAPR Electrode instead of the VAPR 3.5 hook electrode DePuy Mitek, Inc., a Johnson & Johnson Co.
Devices The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Product Usage: Damon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment. Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 Class III The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots, which identified them as maxillary central incisor brackets. Ormco/Sybronendo
Devices AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. Item Code: AL+60000303 Lot #: 11I27, 12B13 Class II Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. Nipro Medical Corporation
Devices AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. Item Code: AL+60000103 Lot #: 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, 12D09 Class II Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. Nipro Medical Corporation
Devices AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. Item Code: AL+60000203 Lot #: 11G02 Class II Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. Nipro Medical Corporation
Devices AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. Item Code: AL+60000003 Lot #: 11F20, 11I27, 12B10 Class II Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. Nipro Medical Corporation
Devices AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. Item Code: AL+60000302 Lot #: 12D05 Class II Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. Nipro Medical Corporation
Devices Osseotite Tapered Certain Implant 5 X 10mm Model INT510 Biomet 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading or with a terminal or intermediary abutment for fixed or removable bridgework and to retain over dentures. Model # INT510, Lot # 2011090751 Class II Biomet 3i recalled their Osseotite Tapered Certain Implant, Model # INT510 due to a small percentage of the devices are missing the internal threading. Biomet 3i, LLC
Devices Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart. Including the left side of the heart through the interatrial septum. Lot no.: W2046680, W2046681, W2072907, W2078460, W2084872, W2098770, W2098771, W2102124, W2102128, W2102133, W2102134, W2108295, W2108296, W2108298, W2108299, W2108300, W2125688, W2125690, W2132584, W2132588, W2132590, W2138965, W2143146, W2143147, W2143149, W2143152, W2145645, W2145677, W2145680, W2145681, W2151287, W2151305, W2151308, W2156746, W2156748, W2156750, W2156751, W2162494, W2162496, W2162497, W2162498, W2162499, W2167985, W2167986, W2167987, W2167988, W2167990, W2172705, W2172706, W2172707, W2172708, W2172710, W2172712, W2177727, W2177728, W2177729, W2177730, W2177733, W2177734, W2184476, W2184483, W2184484, W2184485, W2184487, W2184489, W2190457, W2190461, W2190462, W2190464, W2190470, W2196349, W2196351, W2196352, W2196355, W2196359, W2196361, W2196363, W2211842, W2211844, W2211846, W2211849, W2211850, W2211851, W2211852, W2211853, W2213887, W2213890, W2213892, W2213896, W2213898, W2213901, W2213982, W2221631, W2222017, W2222020, W2222022, W2222024, W2222027, W2222030, W2224408, W2224412, W2224417, W2224421, W2224423, W2224433, W2229959, W2229960, W2229961, W2229963, W2229965, W2229973, W2229974, W2236558, W2236561, W2236588. Class II We are notifying you of a potential interaction between therapeutic catheters and MobiCath Bi-Directional Guiding Sheaths. We became aware of these interactions while investigating recent complaints regarding catheters "self-advancing" while being used in conjunction with the MobiCath Sheaths. Greatbatch Medical
Devices 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair. Model Number 10-55-025, Lot Number 006A1057. Class II A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that one screw of the lot has been shipped. Encore Medical, Lp
Devices HiRes 90K devices with Helix Electrodes Model CI 1400-02H The HiResolution Bionic Ear System is a cochlear implant system designed to provide useful hearing to individuals with severe to profound hearing loss. It consists of internal and external components. The internal components include a stimulator (HiRes90K ICS) and electrode array (HiFocus 1j or Helix). The HiRes90K ICS is implanted surgically under the skin behind the ear. The electrode array is inserted into the cochlea. The external components include a sound processor (body-worn or ear-level), a headpiece, and a cable. The system converts sound into electrical energy that activates the auditory nerve. The auditory nerve then sends information to the brain, where it is interpreted as sound. The Helix consists of a fantail, electrode lead, and Helix electrode array. The electrode, comprised of platinum-iridium wires, is housed in a silicone carrier and extends from the titanium case. The Helix electrode array is 24.5 mm in length and is designed to be inserted approximately 18-21 mm into a normal patent cochlea. It consists of 16 planar contacts arranged along the medial surface of the electrode array for stimulation of discrete segments of the cochlea. The Helix electrode insertion tool is designed to assist the surgeon with the insertion of the Helix electrode. Only the Helix insertion should be used for insertion of the Helix electrode; the use of other instruments may result in damage to the electrode. The insertion tool is a single-use instrument. Serial Numbers: 351323, 251153, 350989, 351226, 350196, 351136, 350140, 350201, 351261, 351264, 351266, 351269, 351412, 351415, 351429, 350157, 351303. Class II Advanced Bionics is recalling the the HiRes 90K cochlear implant with HiFocus Helix Electrode because of loose-fitting insertion tool assemblies. Advanced Bionics Corporation
Devices Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile. Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Class II Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. Sorin Group USA, Inc.
Devices Gish 3/8 x 1/2" Reducer Connector with Luer fitting, Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Product Usage: The connectors are indicated for use in connecting flexible tubing used in extracorporeal blood or fluid circuits. The connectors are distributed as sterile stand alones and bulk non-sterile. Item Numbers: EC2180S, Lot Numbers: 1108900099, 1119900091, 1203700129, 1208600013, 1219200107, Exp. Dates: 3/31/14, 7/31/14, 2/28/15, 3/31/15, 7/31/15. Class II Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. Sorin Group USA, Inc.
Devices Repeater Pump, Class II device used for facilitating repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device are Fluid Transfer Tube Sets, Sterile/EO, Std Volume Trifurcated, BAXA Corporation, Englewood, CO. The Repeater Pump is a device that provides a peristaltic pump driven fluid transfer that facilitates repeatable drug dosage distribution and reconstitution in hospital pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Repeater Pump model #s 095, 099, and 099R. Class II The firm is issuing a field correction to the operators manual included with the 099 Repeater Pump because the Technical Manual was distributed with the device as opposed to the Operator Manual and the instruction for use contradict each other with regards to multiple source container use. Baxa Corporation
Devices Oncentra External Beam 4.1. Radiation treatment planning software designed to analyze and plan radiation treatments in their dimension for the purpose of treating patients with cancer. None as the product is software Class II During the planning process the beam weights can be changed by the customers. When the beam weights are changed and renumbered and this happens during the dose calculation it is possible to save and reopen the plan without any error messages. Elekta, Inc.
Devices GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. Mfg Lot or Serial # 21058, 21002, 21013, 21017, 21020, 21029, 21039, 21041, 21049, 21066, 21075, 21079, 21080, 21081, 21082, 21119, 21140, 21144, 21145, 21147, 21150, 96BH8, 21001, 21008, 21034, 21050, 21056, 21104, 21132, 22003, 22020, 22038, 210088, 21042, 21048, 21061, 21077, 21085, 21094, 21115, 21122, 21123, 21137, 21143, 22051, , 21005, 21072, 21028, 21052, 21076, 21083, 21092, 21101, 21113, 21118, 21131, 21138, 21024, 22001, 22011, 22023, 21019, 21055, 21154, 83BH6 /000, 21007, 21047, 21009, 21021, 21022, 21033, 21035, 21037, 21063, 21064, 21067, 21070, 21073, 21086, 21095, 21121, 21128, 21134, 21141, 21146, 21152, 21153, 22014, 22016, 21003, 21006, 21010, 21027, 21036, 21043, 21046, 21051, 21084, 21108, 21116, 21120, 21124, 21133, 22015, 22028, 21093, 21158, 22021, 21031, 21129, 00ME1, 21004, 21014, 21053, 22005, 21012, 21059, 21151, 22022, 22031, 22035, 21089, 21100, 21136, 22044, 22071, 81BH0 /000, 82BH8 /000, 92BH7 /000, 93BH5 /000, 94BH3, 21016, 21040, 21060, 21103, 21125, 22037, 21038, 22008, 21068, 21126, 22009, 21026, 21011, 21018, 21025, 21071, 21090, 21109, 21110, 21130, 21142, 21160, 21096, 21107, 21091, 21099, 21000, 21023, 21030, 21032, 21044, 21045, 21054, 21062, 21065, 21069, 21074, 21105, 21111, 21114, 21127, 21149, 22002, 22004, 22007, 22010, 22012, 22017, 22018, 22024, 22025, 22026, 22027, 22029, 22030, 22032, 22033, 22034, 22036, 22039, 22040, 22041, 22042, 22043, 22045, 22046, 22047, 22048, 22049, 22050, 22052, 22053, 22054, 22056, 22057, 22059, 22064, 22067, Class II GE Healthcare has recently become aware of a potential safety issue associated with the table pallet of your Discovery NM/CT 670 and/or Discovery NM630 system which may impact operation safety. At scan setup, during gantry rotation towards scanning position, a potential contact between the table-pallet-edge and the detector was identified. Such occurrence may damage the pallet front-edge and raises concern over potential detector-patient contact. GE Healthc