DECEMBER 2009

WEEK ENDING DECEMBER 31

PRODUCT  Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434. CODE
Serial # 00001002491WK7 00000100291WK7 00000999999WK6 00001001816WK6 00001001824WK0 00000995364WK7 00000996497WK4 00000068396WG1 00000995361WK3 00000996218WK4 00000001239M33 00001000600WK5 00000996216WK8 00000001247M36 00000998382WK6 00001001814WK1 00000995360WK5 00001004793WK4 00000998805WK6 00000994499WK2 00001006377WK4 00000997607WK7 00000999065WK6 00001004294WK3 00001005696WK8 00000998799WK1 00000997599WK6 00000992542WK1 00000069597WG3 00001004299WK2 00001002488WK3 00001002487WK5 00000998941WK9 00000998939WK3 00000995356WK3 00000993793WK9 00001000954WK6 00001001827WK3 00000998388WK3 00001005678WK6 00001003046WK8 00001001837WK2 00000035324HL3 00000997608WK5 00001002486WK7 00000998945WK0 00000995366WK2 00000998391WK7 00000994494WK3 00000993374WK8 00000037897HL6 00000001238M35 00000999698WK4 00001003557WK4 00000998383WK4 00001002483WK4 00000999993WK9 00001000956WK1 00000998386WK7 00000997605WK1 00000997602WK8 00000998938WK5 00001001810WK9 00000996491WK7 00001001085WK8 00000035064HL5 00001002490WK9 00001000950WK4 00000996495WK8 00000996791WK0 00000996500WK5 00000996209WK3 00000994488WK5 00000034881HL3 00001000951WK2 00001001799WK4 00001003566WK5 00001003045WK0 0000USU4400NXJ 00000997069WK0 00001002489WK1 00000996498WK2 00001001811WK7 00001000958WK7 00000998392WK5 00000996792WK8 00001004296WK8 00000998944WK3 00001001800WK0 00001003561WK6 00000995353WK0 00001001818WK2 00001005004WK5 00000998937WK7 00000996499WK0 00001002482WK6 00000996212WK7 00001003553WK3 00001000000WK8 00000995349WK8 00000996684WK7 00000998156WK4 00001004304WK0 00000036505HL6 00000994505WK6 00001000952WK0 00000997182WK1 00000998804WK9 00000995368WK8 00000995357WK1 00000994491WK9 00001001807WK5 00000999998WK8 00001005694WK3 00000993794WK7 00001000955WK3 00000064580WG4 00001001822WK4 00001003554WK1 00000998942WK7 00000996789WK4 00001004791WK8 00000996227WK5 00000001173M34 00001000957WK9 00000081110MA9 00001004139WK0 00001004298WK4, and 0000000069365W
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI.
REASON
GE Healthcare has recently become aware of a potential risk of observing a blank image after exposure on Revolution XR/d systems equipped with HP 8200 PC user consoles that may impact patient safety. It was reported that images acquired with off-center collimation for extremities with the position selected as Digits to front or Digits to back are displayed as blank. Investigation into this issue revealed an error in the Revolution XR/d image processing software that controls rotation of collimator coordinates. This error causes the system to display a blank image when Digits to front or Digits to back are selected for off-center collimation exams.
VOLUME OF PRODUCT IN COMMERCE
129 units
DISTRIBUTION Nationwide

PRODUCT  MilCAM Recon III Model Family of IR Imagers that incorporate a Class I infrared laser for Laser Range Finding (LRF). 
CODE n/a
RECALLING FIRM/MANUFACTURER
Flir Systems, Inc., North Billerica, MA, 
REASON
LRF models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations, Subchapter J, Parts 1000 - 1050 (21 CFR 1000 - 1050). A filter defect allows transmission of laser energy such that the affected LRF would be Class 3B laser product, however the product is reported to CDRH as a Class I product.
VOLUME OF PRODUCT IN COMMERCE
120 units
DISTRIBUTION Nationwide

PRODUCT  MilCAM Recon III, Family of IR Imagers that incorporates a Class IIIb infrared laser pointer. CODE
Serial numbers: AH0260 AH0264 AH0259 AH0257 AH0250 AH0261 AH0258 AH0467 AH0413 AH0414 AH0415 AH0416 AH0417 AH0450 AH0451 AH0456 AH0458 AH0459 AH0460 AH0462 AH0464 AH0465 AH0461 AH0453 AH0454 AH0452 AH0455 AH0457 AH0463 AH0414 AH0466 AH0468 AH0599 AH0600 AH0606 AH0601 AH0608 AH0597 AH0596 AH0602 AH0470 AH0595 AH0607 AH0471 AH0603 AH0469 AH0609 AH0598 AH0604 AH0605 AH0610 AH0613 AH0611 AH0612, and AH0614
RECALLING FIRM/MANUFACTURER
Flir Systems, Inc., North Billerica, MA, 
REASON
MilCAM Recon III models were sold to non-DoD customers prior to certification and reporting as required in Title 21 of the Code of Federal Regulations. Conditions of sale were not stated in variance approval letters issued for similar laser products.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION Nationwide

PRODUCT 
1) GE Healthcare CT Systems Table Model Number 2225283 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. 

2) GE Healthcare CT Systems Table Model Number 2271242 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. 

3) GE Healthcare CT Systems Table Model Number 2269165 used on LightSpeed 1X through 4X and HiSpeed Qxi CT Systems. 
CODE
1) All tables and serial numbers associated with Model Number 2225283;
2) All tables and serial numbers associated with Model Number 2271242;
3) Tables, with associated serial numbers, built before FW20, 2002
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, 
REASON
Failure to provide the certification label required by 21 CFR 1010.2.
VOLUME OF PRODUCT IN COMMERCE
1179 units
DISTRIBUTION Nationwide

PRODUCT Celex/GE Precision MPi, REF no.: 02980000 Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. 
CODE
Serial Numbers: 507003, 507004, 507005, 510004, 510009, 510010, 513001, 513003, 513007, 518001, 518002, 518004, 518005, 518006, 518011, 518013, 518014, 518015, 518017, 518018, 518020, 522001, 522002, 522003, 522004, 522005, 522006, 522008, 522009, 522012, 522014, 522015, 522016, 522018, 522019, 536001, 536002, 536003, and 536007
RECALLING FIRM/MANUFACTURER
NRT - Nordisk Rontgen Teknik A/S, Hasselager, Denmark, 
REASON
The GE Precision MPi is in violation with 21 CFR Part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.
VOLUME OF PRODUCT IN COMMERCE
40 units
DISTRIBUTION Nationwide

PRODUCT 
1) GE Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. 

2) Innova 3100, Cardiovascular Imaging System, GE Healthcare, Waukesha, WI 53188 (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. 

3) GE Innova 3100-IQ, Cardiovascular Imaging System, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures.

4) GE Innova 4100, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. 

5) GE Innova 4100-IQ, (The system consists of a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. 
CODE
1) Serial Numbers: 00000549014BU9 00000559113BU6 00000468132BU6 00000550787BU6 00000476562BU4 00000504278BU3 00000541267BU1 00000504213BU0 00000543793BU4 00000471654BU4 00000493726BU4 00000484054BU2 00000480361BU5 00000491716BU7 00000480141BU1 00000478109BU2 00000551073BU0 00000542139BU1 00000548596BU6 00000568569BU8 00000492255BU5 00000548503BU2 00000545486BU3 00000552387BU3 00000485315BU6 00000558901BU5 00000466659BU0 00000470059BU7 00000466984BU2 00000572055BU2 00000505180BU0 00000499524BU7 00000473103BU0 00000544810BU5 00000566379BU4 00000566835BU5 00000499523BU9 00000500515BU0 00000571259BU1 00000472240BU1 00000499386BU1 00000559819BU8 00000551081BU3 00000484361BU1 00000564503BU1 00000549262BU4 00000551080BU5 00000520192BU6 00000490443BU9 00000476249BU8 00000461599BU3 00000533867BU8 00000537820BU3 00000054776BU4 00000548841BU6 00000543266BU1 00000551641BU4 00000512954BU9 00000493888BU2 00000518354BU6 00000553078BU1 00000469582BU1 00000545962BU3 00000485032BU7 00000566594BU8 00000468193BU8 00000570102BU4 00000569024BU3 00000545490BU5 00000543797BU5 00000509365BU3 00000560479BU8 00000479585BU2 00000548595BU8 00000543796BU7 00000531109BU7 00000552382BU4 00000460641BU4 00000460969BU9 00000550786BU8 00000504275BU9 00000493887BU4 00000563630BU3 00000552746BU0 00000563628BU7 00000531111BU3 00000569371BU8 00000513959BU7 00000466830BU7 00000473099BU0 00000479758BU5 00000479243BU8 00000477389BU1 00000500616BU8 00000509440BU4 00000566146BU7 00000491709BU2 00000543076BU4 00000546168BU6 00000561529BU9 00000509441BU2 00000491706BU8 00000562976BU1 00000553276BU7 00000477893BU2 00000546167BU8 00000560911BU0 00000515486BU9 00000537597BU7 00000564215BU2 00000538055BU5 00000493727BU2 00000562518BU1 00000508010BU6 00000559585BU5 00000560474BU9 00000552390BU7 00000483161BU6 00000559233BU2 00000479216BU4 00000465375BU4 00000483162BU4 000000006U0007 00000533870BU2 00000552055BU6 00000556787BU0 00000500612BU7 00000567993BU1 00000569026BU8 00000567352BU0 00000567338BU9 00000509439BU6 00000464559BU4 00000463841BU7 00000479937BU5 00000499840BU7 00000567334BU8 00000493725BU6 00000544289BU2 00000560909BU4 00000552385BU7 00000469466BU7 00000543169BU7 00000542273BU8 00000467455BU2 00000492106BU0 00000546157BU9 00000492922BU0 00000567350BU4 00000552386BU5 00000565106BU2 00000517924BU7 00000547292BU3 00000538034BU0 00000513294BU9 00000471760BU9 00000548165BU0 00000471487BU9 00000468168BU0 00000476109BU4 00000523240BU0 00000461379BU0 00000542138BU3 00000478363BU5 00000504277BU5 00000480315BU1 00000480140BU3 00000479701BU5 00000476013BU8 00000492457BU7 00000513296BU4 00000538053BU0 00000545052BU3 00000541271BU3 00000477463BU4 00000511494BU7 00000548592BU5 00000551634BU9 00000468192BU0 00000469465BU9 00000470060BU5 00000545048BU1 00000523777BU1 00000545046BU5 00000461266BU9 00000523086BU7 00000516769BU7 00000538572BU9 00000537027BU5 00000540176BU5 00000553269BU2 00000491032BU9 00000543265BU3 00000543798BU3 00000548598BU2 00000540174BU0 00000544495BU5 00000542274BU6 00000510844BU4 00000541966BU8 00000476725BU7 00000492136BU7 00000569021BU9 00000513958BU9 00000530413BU4 00000549261BU6 00000543799BU1 00000560472BU3 00000478275BU1 00000492243BU1 00000476685BU3 00000545588BU6 00000465560BU1 00000543269BU5 00000509136BU8 00000537449BU1 00000523241BU8 00000491172BU3 00000551444BU3 00000522942BU2 00000564216BU0 00000008C20126 00000565614BU5 00000563636BU0 00000551443BU5 and 00000545589BU4;

2) Serial Numbers: 00000529517BU5 00000458534BU5 00000435031BU0 00000566382BU8 00000512956BU4 00000550134BU1 00000549706BU0 00000523132BU9 00000537463BU2 00000547770BU8 00000446090BU3 00000491058BU4 00000537465BU7 00000476260BU5 00000530412BU6 00000555080BU1 00000437215BU7 00000465048BU7 00000482707BU7 00000541969BU2 00000488003BU5 00000545420BU2 00000556280BU6 00000484393BU4 00000544285BU0 00000523134BU5 00000477394BU1 00000482419BU9 00000551636BU4 00000509132BU7 00000568027BU7 00000543272BU9 00000545590BU2 00000548338BU3 00000482661BU6 00000440229BU3 00000521654BU4 00000544808BU9 00000565460BU3 00000520189BU2 00000512758BU4 00000509817BU3 00000545421BU0 00000482188BU0 00000477767BU8 00000557461BU1 00000445301BU5 00000543795BU9 00000424103BU0 00000545419BU4 00000454181BU9 00000449819BU2 00000463520BU7 00000552743BU7 00000548601BU4 00000442172BU3 00451726BU4BU8 00000497601BU5 00000438668BU6 00000492274BU6 00000505219BU6 00000567995BU6 00000571256BU7 00000465766BU4 00000466810BU9 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00000493235BU6 00000559582BU2 00000470052BU2 00000417617BU8 and 00000432299BU6
RECALLING FIRM/MANUFACTURER
GE Healthcare, Waukesha, WI
REASON
During a Maximum Air Kerma Rate (AKR) calibration procedure check, GE Healthcare found the AKR calibration procedure does not exactly reflect the worst-case clinical usage of the product. This may result, when using large Equivalent Patient Thickness and in some rare cases of system/set-up combinations, in a non-compliance with 21 CFR 1020.32. The non-compliance may exceed the regulatory standard limit of 88mGy/min (10 R/min) by 6% (90.6 4mGy/min or 10.63R/min). The system works properly until the point where the maximum Air Kerma Rate is reached (88mGy/min or 10R/min).
VOLUME OF PRODUCT IN COMMERCE
929 units
DISTRIBUTION Nationwide

PRODUCT  Jejunal Feeding Set, Product Order number FLOWJ-9-20. This device is used for percutaneous endoscopic placement to provide internal nutrition to patients requiring nutritional support. 
CODE Lot number W2676476
RECALLING FIRM/MANUFACTURER
Cook Endoscopy, Winston Salem, NC, 
REASON
The English only version of the Patient Care Manuals that accompany the device were shipped to a medical facility in Italy.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION Italy

PRODUCT  iPulse Circulatory Support System Catalog number: 0036-0010 The iPulse System Console is a multi-purpose mechanical circulatory support system used to support patients suffering from acute cardiovascular failure. The iPulse console can be used to drive exclusively one of two classes of therapeutic devices: either pneumatically actuated Ventricular Assist Devices (VADs) for total circulatory support, or (i.e., non-simultaneously) an intra-aortic balloon (IAB) catheter for counter-pulsation therapy. 
CODE
Serial numbers: SC1000, SC1001, SC1003 - SC1010, SC1014 - SC1023, SC1025 - SC1070, SC1072 - SC1081, SC1083, SC1084, and SC1089
RECALLING FIRM/MANUFACTURER
Abiomed, Inc., Danvers, MA,
REASON
iPulse Console SC1035 displayed a "Low Pressure / Low Flow" alarm and stopped pumping during patient transport in battery operation.
VOLUME OF PRODUCT IN COMMERCE
79 units
DISTRIBUTION Nationwide, Germany, Greece, Italy, Latvia, Spain, and Turkey

PRODUCT  ACT3020 Advanced Cutting technology (ACT) Twist Drill 3.0mm(D) X 20mm(L). Made in Switzerland. Twist drill for preparation of osteotomy during dental implant surgical drilling procedure. 
CODE Lot # 860172
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet 3i, LLC, Palm Beach Gardens, FL,
Manufacturer: Dentsply Maillefer, Ballaigues, Switzerland. 
REASON
Some of the packages of ACT3020, drills may actually contain an ACT3220 drill.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION Nationwide, Korea, Netherlands, Taiwan, United Kingdom

PRODUCT  BioTek Gen5CL Microplate Data Collection and Analysis Software. Intended for clinical lab use with ELx800 and ELx808 microplate readers, offers preprogrammed clinical diagnostic assays within a PC-based application. CODE Software versions 1.07 and lower
RECALLING FIRM/MANUFACTURER
BioTek Instruments, Inc., Winooski, VT, 
REASON
Software design allowed false negatives to be read when wells are dark.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION MN, CA, IL, MA, MI, CA, GA, FL, AZ and TX and Peru

PRODUCT  Applied Medical 15x100mm Kii Optical Access System, Non-Threaded 6/Box, Model Number: C0R36, Labeled Sterile. Disposable single-use devices indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgeries. Endoscopic instruments for surgery. CODE Lot Numbers:1084426 and 1085506
RECALLING FIRM/MANUFACTURER
Applied Medical Resources Corp., Rancho Santa Margarita, CA
REASON
Applied Medical is conducting a coluntary recall of two lot numbers, 1084426 and 1085506, of the 15mm Kii non-threaded optical access system, model C0R36, due to a potential weakness in the cannula tip, possibly resulting in tip breakage.
VOLUME OF PRODUCT IN COMMERCE
934 units
DISTRIBUTION Nationwide, Australia, New Zealand, France, Canada, Norway and Great Britain

PRODUCT 
1) St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. 

2) St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM. Guidewire O.D .038", 2010-01, Sterile EO. Used for the introduction of catheters into a vessel. 
CODE
1) Lot Number: 6372;
2) Lot Number: 4219
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Minnetonka, MN
REASON
St. Jude Medical has initiated a voluntary recall of two lots of Fast-Cath Hemostasis Introducers-reorder number 406709, lot number 4219 and reorder number 406702, lot number 6372. They discovered that the product lots could contain some items which have been mis-labeled with the incorrect French size. In one case, the pouch label does not correctly identify the content of the pouch. In another case, the carton label is incorrect. The pouch label indicated that the product was 4F catheter, but the contents of the pouch may be a 7F catheter. St. Jude Medical has not received any reports of injuries resulting from this mis-labeling.
VOLUME OF PRODUCT IN COMMERCE
2,490 units
DISTRIBUTION CA, MI, PA, TN, China and Belgium

PRODUCT  ZOLL R Series Defibrillator/Pacemaker/Monitor Used by qualified medical personnel for the purpose of converting ventricular fibrillation to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats. CODE
Serial numbers: AF07F001253 AF07I002116 AF08A003438 AF08D004586 AF08F005082 AF08F005110 AF08G005269 AF08H005383 AF08I005615 AF08I005627 AF08I005646 AF08I005659 AF08I005709 AF08J005735 AF08J005757 AF08J005768 AF08J005776 AF08K005996 AF08K006000 AF08K006007 AF08K006017 AF08K006053 AF08K006102 AF08L006282 AF08L006358 AF08L006359 AF08L006397 AF08L006412 AF08L006442 AF08L006447 AF08L006457 AF08L006462 AF08L006501 AF08L006503 AF08L006508 AF08L006512 AF08L006514 AF08L006515 AF08L006516 AF08L006517 AF08L006518 AF08L006519 AF08L006520 AF08L006521 AF08L006522 AF08L006524 AF08L006528 AF08L006530 AF08L006531 AF08L006532 AF08L006533 AF08L006534 AF08L006535 AF08L006545 AF08L006546 AF08L006547 AF08L006551 AF08L006556 AF08L006558 AF08L006559 AF08L006560 AF08L006565 AF08L006568 AF08L006574 AF08L006575 AF08L006577 AF08L006578 AF08L006579 AF08L006580 AF08L006582 AF08L006583 AF08L006584 AF08L006585 AF08L006586 AF08L006587 AF08L006589 AF08L006590 AF08L006591 AF08L006592 AF08L006593 AF08L006594 AF08L006596 AF08L006598 AF08L006599 AF08L006600 AF08L006601 AF08L006603 AF08L006604 AF08L006605 AF08L006606 AF08L006607 AF08L006609 AF08L006610 AF08L006611 AF08L006612 AF08L006613 AF08L006614 AF08L006619 AF08L006620 AF08L006621 AF08L006622 AF08L006624 AF08L006625 AF08L006626 AF08L006627 AF08L006628 AF09B006680 AF09B006681 AF09B006682 AF09B006684 AF09B006685 AF09B006686 AF09B006688 AF09B006690 AF09B006709 AF09B006712 AF09B006714 AF09B006715 AF09B006716 AF09B006718 AF09B006724 AF09B006726 AF09B006727 AF09B006728 AF09B006732 AF09B006736 AF09B006737 AF09B006739 AF09B006740 AF09B006744 AF09B006745 AF09B006748 AF09B006761 AF09B006762 AF09B006765 AF09B006766 AF09B006767 AF09B006768 AF09B006770 AF09B006772 AF09B006774 AF09B006775 AF09B006776 AF09B006777 AF09B006778 AF09B006779 AF09B006780 AF09B006781 AF09B006782 AF09B006783 AF09B006784 AF09B006785 AF09B006786 AF09B006787 AF09B006789 AF09B006791 AF09B006794 AF09B006795 AF09B006798 AF09B006799 AF09B006800 AF09B006801 AF09B006802 AF09B006806 AF09B006807 AF09B006808 AF09B006809 AF09B006810 AF09B006811 AF09B006812 AF09B006813 AF09B006814 AF09B006815 AF09B006816 AF09B006818 AF09B006819 AF09B006820 AF09B006821 AF09B006824 AF09B006825 AF09B006827 AF09B006828 AF09B006830 AF09B006831 AF09B006832 AF09B006834 AF09B006836 AF09B006837 AF09B006838 AF09B006839 AF09B006840 AF09B006841 AF09B006842 AF09B006844 AF09B006845 AF09B006846 AF09B006847 AF09B006859 AF09B006860 AF09B006861 AF09C006880 AF09C006881 AF09C006883 AF09C006884 AF09C006888 AF09C006894 AF09C006895 AF09C006896 AF09C006899 AF09C006905 AF09C006912 AF09C006915 AF09C006928 AF09C006929 AF09C006930 AF09C006931 AF09C006932 AF09C006933 AF09C006934 AF09C006937 AF09C006939 AF09C006940 AF09C006942 AF09C006956 AF09C006957 AF09C006958 AF09C006959 AF09C006960 AF09C006961 AF09C006962 AF09C006964 AF09C006968 AF09C007103 AF09C007104 AF09C007106 AF09C007107 AF09C007108 AF09C007109 AF09C007110 AF09C007111 AF09C007130 AF09C007132 AF09C007194 AF09C007200 AF09C007427 AF09D007485, and AF09F007805
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corporation, World Wide Headquarters, Chelmsford, MA, 
REASON
Failure of Device to display ECG could delay delivery of defibrillation or pacing therapy.
VOLUME OF PRODUCT IN COMMERCE
247 units
DISTRIBUTION Nationwide, UK, Austria, Australia,, Canada, Switzerland, Germany, France, French Guiana, Jordan, Macedonia, Netherlands, Panama, Poland, Romania, and Saudi Arabia

PRODUCT 
1) TI Cann Partl Thd Recon Screw 6.00MM x 65MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406065. 

2) TI Cann Partl Thd Recon Screw 6.00MM x 70MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406070. 

3) TI Cann Partl Thd Recon Screw 6.00MM x 75MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406075. 

4) TI Cann Partl Thd Recon Screw 6.00MM x 80MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406080. 

5) TI Cann Partl Thd Recon Screw 6.00MM x 85MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item 14-406085. 

6) TI Cann Partl Thd Recon Screw 6.00MM x 90MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406090. 

7) TI Cann Partl Thd Recon Screw 6.00MM x 95MM; Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-406095. 

8) TI Cannulated Screw 20MM thrd 6.5MM (d) X 85MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245846. 

9) TI Cannulated Screw 32MM thrd 7.3MM (d) X 95MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245958.

10) TI Cannulated Screw 32MM thrd 7.3MM (d) X 100MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number: 245960.

11) TI Cannulated Screw 32MM thrd 7.3MM (d) X 120MM (L); Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 245968. 

12) TI Screw Buttress Thread 5MM (D) x 35MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345424. 

13) TI Screw Buttress Thread 6MM (D) x 65MM (L) Trauma Fixation Systems, Rx Only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 33-345534. 

14) Bone Screw 5.5MM X 45MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27445. 

15) Bone Screw 5.5MM X 55MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27455. 

16) Bone Screw 5.5MM X 70MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 274470. 

17) Bone Screw 4.5MM X 20MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27820. 

18) Bone Screw 4.5MM X 28MM Bone Screw Lock, Rx only. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27828. 

19) Bone Screw 4.5MM X 36MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27836. 

20) Bone Screw 4.5MM X 52MM Bone Screw Lck-Cann, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27852. 

21) Bone Screw .5MM X 60MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27860. 

22) Bone Screw 4.5MM X 70MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27870. 

23) Bone Screw4.5MM X 95MM Bone Screw Lock, Rx only; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 27895. 

24) Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 2000-3445.

25) C-Tek Maxan Anterior Cervical Plate System; 4.0MM X 20MM Fixed Screw'; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 14-521520. 

26) Pediatric Femoral Nail 5.5MM (d) x 28 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24128. 

27) Pediatric Femoral Nail 5.5MM (d) x 30 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24130. 

28) Pediatric Femoral Nail 5.5MM (d) x 32 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24132. 

29) Pediatric Femoral Nail 5.5MM (d) x 36 CM (L) Rx only, Sterile; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Item number 24136. 

30) Fixed Closed Screw, 6.5mm (D) x 40mm (L), Made in USA; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog number 6147. 

31) Fixed Open Screw (TI); 7.0MM (D) x 30MM (L); Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7140. 

32) Fixed Closed Screw (Ti); 5.0MM (D) x 25MM (L); Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7155. 

33) Fixed Closed Screw (Ti); 6.0MM (D) x 40 MM (L) Made In USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 7162. 

34) Bone Screw 6MM (D) x 35MM (L) Telescopic Plate Spacer, Thoracolumbar Spinal System Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 1300-0635. 

35) Bone Screw 7MM (D) x 35 MM (L) Telescopic Plate Spacer Thoracolumbar Spinal System; Made in USA. The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number: 1300-0735.

36) Multi-Axial Screw (TI); 8.00MM (D) x 70MM(L) W/Collar; The screw devices are an internal fixation device intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Implants used in this application include non sterile and sterile bone screws. Catalog Number 6588. 
CODE
1) Lot number 517260;
2) Lot number 517270;
3) Lot number 517280;
4) Lot number 517290;
5) Lot number 517300;
6) Lot number 517320;
7) Lot number 517330;
8) Lot number 665220;
9) Lot number 668110;
10) Lot number 688120;
11) Lot number 688130;
12) Lot numbers 733230, 733240, 733250;
13) Lot numbers 599000, 616450, 618520;
14) Lot number 708310;
15) Lot number 721730;
16) Lot number 741840;
17) Lot number 697550;
18) Lot number 697560;
19) Lot number 716900;
20) Lot number 696110;
21) Lot number 717040, 721480;
22) Lot numbers 741860, 744730;
23) Lot number 717050;
24) Lot numbers 705610, 710680, 741900;
25) Lot number 840070;
26) Lot numbers 612010, 658220;
27) Lot number 557430;
28) Lot number 557440;
29) Lot number 798630;
30) Packaging Lot # 885870, Unpackaged Lot # 605992;
31) Packaging Lot # 825200/894010, Unpackaged lot #605121;
32) Packaging Lot # 641010, Unpackaged Lot 605122;
33) Packaging Lot # 723910, Unpackaged Lot # 605125;
34) Packaging Lot: 691780, Unpackaged lot: 605339;
35) Packaging Lot: 703250, Unpackaged lot 605340;
36) Packaging Lot: 651150, Unpackaged lot 605119
RECALLING FIRM/MANUFACTURER
EBI, L.P., Parsippany, NJ, 
REASON
Some devices could have been made with raw material lots that may have inclusions, and could result in decreased strength of the device.
VOLUME OF PRODUCT IN COMMERCE
708 units
DISTRIBUTION Nationwide, Brazil, Colombia, Denmark, Germany, Finland, Greece, Italy, Japan, The Netherlands, Switzerland, Sweden, Portugal, Spain, United Kingdom, Saudi Arabia, and Trinidad

WEEK ENDING DECEMBER 26

PRODUCT Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. 
CODE
Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc., Malvern, PA, 
REASON
Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
VOLUME OF PRODUCT IN COMMERCE
17,236 units
DISTRIBUTION FL, MN

PRODUCT 
1) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile; REF 00-2490-001-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

2) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

3) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile; REF 00-2490-001-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

4) Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

5) Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile; REF 00-2490-005-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

6) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile; REF 00-2490-008-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

7) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile; REF 00-2490-008-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

8) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile; REF 00-2490-001-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

9) Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile; REF 00-2490-001-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

10) Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile; REF 00-2490-001-53. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

11) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile; REF 00-2490-008-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

12) Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, REF 00-2490-008-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

13) Zimmer Natural Nail System, REF 00-2490-005-04. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. 

14) Zimmer Natural Nail System, REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. CODE
1) Lots 61219397, 61228025 and 61277887;
2) Lot 61221481;
3) Lot 61291761;
4) Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542;
5) Lots 61161122, 61175552, 61217393, 61248664 and 61233593;
6) Lot 61227883;
7) Lot 61297069;
8) Lots 00111581, 61229463, 61232451, 61284938 and 61284939;
9) Lots 61221482, 61241809 and 61248640;
10) Lot 61221483;
11) Lot 61227882;
12) Lot 61227880;
13) Lots 61161124 and 61170214;
14) Lot 61161453
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN,
REASON
The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
VOLUME OF PRODUCT IN COMMERCE
327 units
DISTRIBUTION Nationwide, France, Germany, Italy, Switzerland and United Kingdom

PRODUCT
1) Scorpio CR Basic Femur with Posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-3007R. 

2) Scorpio CR Waffle Femur Lfit with posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-4107R. 

3) Scorpio PS Basic Femur. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-3003L, and Catalog number 71-3005R. 

4) Scorpio PS Femur Waffle Posts with LfIt. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-4505L, and Catalog number 71-4505R. 

5) Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4405L, and Catalog number 80-4405R. 

6) Scorpio NRG Cruciate Retaining Femoral, Right # 7. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4407R. 

7) Scorpio NRG Cruciate Retaining Femoral, Left # 8. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4408L. 

8) Scorpio NRG Posterior Stabilized Femoral, #3 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4403L. 

9) Scorpio NRG Posterior Stabilized Femoral. # 4 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4404L, and Catalog number 81-4404R. 

10) Scorpio NRG Posterior Stabilized Femoral, # 5 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4405L. 

11) Scorpio NRG Posterior Stabilized Femoral, # 7 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4407L and Catalog number 81-4407R. 

12) Scorpio NRG Posterior Stabilized Femoral, #9 left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4409L, 
CODE
1) 1) Lot code MHHR5W;
2) Lot code MHHDME;
3) Lot code MHHK2X and lot code MHH378;
4) Lot code MHHT6L and lot codes L MHHL20 and MHHR6;
5) Lot codes MHJ1HW and MHJ4RV and Lot codes: MHE4E0 and MHJ4RW;
6) Lot code MHJ09J;
7) Lot code MHH8J4;
8) Lot codeMHEJ9R;
9) Lot code MHHDR0 and lot code MHHN7J;
10) Lot code MHHKXX;
11) Lot code MHHEY8 and lot codes: MHHAEV and MHHM4K;
12) Lot code MHHK14
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
REASON
It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION MA, NJ, IN, MI, CA, PA, Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, the United Kingdom

PRODUCT Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries. 
CODE
US Lot # 7821740 and Outside US Lot # 7821736
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, 
REASON
ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION TX, FL, Germany, France and United Kingdom

PRODUCT Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52. 
CODE Lot 61042477
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, 
REASON
The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION Nationwide, Korea and Switzerland

PRODUCT 
1) Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12.

2) Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14. CODE
1) Lot Numbers: 624239, 624240;
2) Lot Numbers: 624241, 624242, 625418
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA,
REASON
Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
VOLUME OF PRODUCT IN COMMERCE
321 units
DISTRIBUTION Nationwide

PRODUCT
1) Merit Medical Systems, Inc. Connection Tube label reading in part: Connecting Tube 12" Sterile K10-04129, Catalog number K10-04129 Connection tubing can be used with any drainage catheter and drainage bag. 

2) Merit Medical Systems, Inc. Connection tubes label reading in part: Connecting Tube w/ Stopcock 12" Catalog number K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag. 

3) Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: Monarch Catalog number IN2130 for inflation and deflation of interventional devices.

4) Merit Medical Systems, Inc. Monarch Inflation Syringe Catalog number IN2230 for inflation and deflation of interventional devices. 

5) Merit Advance Angiographic Needle label reading in part: Majestik Series Angiographic Needles 20 G Catalog number AN20T52C for the introduction of vascular access devices. 

6) Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe. 

7) Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220. 

8) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. 

9) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. 

10) Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. 

11) Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology procedures. 

12) Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents. 

13) Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures. 

14) Merit Medical Systems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag Catalog number PIB500 Used to apply pressure to a sealed bag of sterile fluid. 

15) Merit Medical systems, Inc, Convenience Kit REF/CAT #: K09-07692 Revision A, Custom Kit. CODE
1) Lot # F709636;
2) Lot # F720653
3) Lot # F730935;
4) Lot # F730934;
5) Lot # F611693;
6) Lot # D918208;
7) Lot # D923107;
8) Lot # F696474;
9) Lot # F732268S1;
10) Lot # F712835;
11) Lot # F733058;
12) Lot # 9H4824;
13) Lot # D914622;
14) Lot # 9H42824;
15) Lot # F726849
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, 
REASON
Potential sterility breach caused by excessive shipment damage.
VOLUME OF PRODUCT IN COMMERCE
352 units
DISTRIBUTION AL, LA, MO, KY, TN, GA

PRODUCT Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system. CODE Lots 47PN, 47PP, 49HK, 49HL and 57WL
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN,
Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. 
REASON
The tip of the instrument may fracture during use.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION Nationwide, Belgium and New Zealand

PRODUCT Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01.
CODE Lot 07878240
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN,
REASON
Smaller diameter screws than required were included in the package.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION CT, IN, PA, Australia, Serbia, Spain, Switzerland and the United Kingdom

PRODUCT 
1) Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads. Catalog numbers: J6051-0425, J0651-0525, J6051-0625. 

2) Stryker Howmedica Osteonics, Primary Super SecurFit Stems, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads. Catalog Number: J6054-XXXX. 
CODE All lots with an expiry prior to August 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. 
REASON
Stryker Orthopedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
VOLUME OF PRODUCT IN COMMERCE
786 units
DISTRIBUTION Nationwide

PRODUCT Zimmer/CAS Power Cord, Sesamoid Plasty, NA; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains. 
CODE
Serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN,
Manufacturer: Zimmer CAS, Montreal, Canada. 
REASON
The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION Nationwide

PRODUCT E-Z CLEAN Non Stick Cautery Tip. Label reads in part: CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. 
CODE Lot Number: 91469
RECALLING FIRM/MANUFACTURER
Megadyne Medical Products, Inc., Draper, UT, 
REASON
Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION CA, FL, NE, LA, MT, OK, OR, PA, SC and UT and New Zealand

Encompass Group Recalls Thermoflect Product Line 

Jea R. Gackowski, Encompass Group Corporate Compliance Officer is recalling the Thermoflect product line for relabeling regarding its use in the MR (Magnetic Resonance) environment.

Thermoflect products are distributed nationally and internationally.  A complete list of Thermoflect products and additional information can be found at www.thermoflect.com.

For More Information, contact
Jea R. Gackowski, C.H.B., C.C.S.
Corporate Compliance Officer
770-626-2044
Monday – Friday 9 a.m. – 5 p.m. eastern.

WEEK ENDING DECEMBER 19

PRODUCT
1) Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label. 4 model (catalog) numbers are affected: M3860A, M3861A, M3840A, and M3841A. Specifics for each code: M3860A: Philips Heartstart FR2+ Defibrillator with ECG Module (various languages) M3861A: Philips Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). M3840A: Laerdal Branded Heartstart FR2+ Defibrillator with ECG Module (various languages). M3841A: Laerdal Branded Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement. 

2) Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. R
CODE
1) Following serial numbers listed as follows: M3860A=U.S. Distribution M3861A=U.S. Distribution M3860A=Canadian Distribution M3861A=Canadian Distribution M3860A=International, not including Canada M3861A=Interantional, not including Canada Laerdal=M3840A and M3841A=all international M3860A U.S. DISTRIBUTION: 0108267575, 0807248065, 0807248798, 0807249110, 0807250145, 0907253534, 0907254125, 0907254417, 0907254602, 0108267741, 0807248084, 0807248802, 0807249112, 0807250147, 0907253540, 0907254127, 0907254421, 0907254603, 0307230176, 0807248100, 0807248804, 0807249113, 0807250166, 0907253544, 0907254129, 0907254423, 0907254604, 0507237301, 0807248160, 0807248806, 0807249116, 0807250177, 0907253546, 0907254132, 0907254425, 0907254605, 0507237302, 0807248166, 0807248815, 0807249118, 0807250179, 0907253548, 0907254133, 0907254427, 0907254606, 0507237303, 0807248168, 0807248827, 0807249122, 0807250198, 0907253552, 0907254136, 0907254429, 0907254607, 0507237304, 0807248172, 0807248830, 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0907254981, 0707244388, 0807248695, 0807249031, 0807250042, 0907253499, 0907254104, 0907254395, 0907254590, 0907254983, 0707244494, 0807248699, 0807249033, 0807250059, 0907253502, 0907254108, 0907254396, 0907254591, 0907254985, 0707245904, 0807248732, 0807249035, 0807250079, 0907253503, 0907254111, 0907254397, 0907254592, 0907254987, 0707246078, 0807248734, 0807249037, 0807250097, 0907253504, 0907254114, 0907254399, 0907254593, 0907254989, 0707246276, 0807248736, 0807249039, 0807250101, 0907253507, 0907254115, 0907254401, 0907254594, 0907254991, 0807247654, 0807248750, 0807249041, 0807250103, 0907253512, 0907254116, 0907254403, 0907254595, 0907254993, 0807247692, 0807248754, 0807249043, 0807250109, 0907253520, 0907254117, 0907254405, 0907254596, 0907254995, 0807247809, 0807248756, 0807249045, 0807250113, 0907253524, 0907254119, 0907254407, 0907254597, 0907254997, 0807247811, 0807248758, 0807249101, 0807250117, 0907253526, 0907254120, 0907254409, 0907254598, 0908287926, 0807248037, 0807248764, 0807249106, 0807250129, 0907253528, 0907254121, 0907254411, 0907254599, 0908287992, 0807248059, 0807248766, 0807249107, 0807250135, 0907253530, 0907254122, 0907254413, 0907254600, 1007255537, 0807248063, 0807248768, 0807249109, 0807250144, 0907253532, 0907254123, 0907254415, AND 0907254601.

================================================== M3861A U.S. DISTRIBUTION: 0108267721, 0807248357, 0907253438, 0907254101, 0907254280, 0907254452, 0907254699, 0907254819, 0108267727, 0807248359, 0907253485, 0907254103, 0907254282, 0907254454, 0907254700, 0907254820, 0308273383, 0807248361, 0907253487, 0907254106, 0907254284, 0907254456, 0907254701, 0907254821, 0507237606, 0807248373, 0907253488, 0907254109, 0907254288, 0907254458, 0907254702, 0907254822, 0507237614, 0807248379, 0907253489, 0907254110, 0907254290, 0907254460, 0907254703, 0907254824, 0507237737, 0807248381, 0907253491, 0907254112, 0907254291, 0907254464, 0907254704, 0907254825, 0507237897, 0807248399, 0907253495, 0907254113, 0907254293, 0907254466, 0907254705, 0907254827, 0607239687, 0807248460, 0907253496, 0907254126, 0907254294, 0907254468, 0907254706, 0907254828, 0607239744, 0807248514, 0907253519, 0907254128, 0907254296, 0907254470, 0907254707, 0907254829, 0607239756, 0807248518, 0907253538, 0907254130, 0907254298, 0907254472, 0907254708, 0907254830, 0607239890, 0807248525, 0907253542, 0907254134, 0907254300, 0907254474, 0907254709, 0907254831, 0607239947, 0807248531, 0907253557, 0907254135, 0907254302, 0907254476, 0907254710, 0907254832, 0607239957, 0807248533, 0907253611, 0907254138, 0907254304, 0907254478, 0907254711, 0907254833, 0607240006, 0807248539, 0907253660, 0907254145, 0907254306, 0907254480, 0907254712, 0907254835, 0607240106, 0807248564, 0907253667, 0907254147, 0907254308, 0907254490, 0907254713, 0907254838, 0607240112, 0807248583, 0907253668, 0907254148, 0907254310, 0907254502, 0907254714, 0907254840, 0607240124, 0807248595, 0907253669, 0907254149, 0907254312, 0907254506, 0907254715, 0907254841, 0607240126, 0807248634, 0907253671, 0907254151, 0907254314, 0907254510, 0907254717, 0907254843, 0607240521, 0807248645, 0907253672, 0907254152, 0907254316, 0907254514, 0907254718, 0907254844, 0607241459, 0807248684, 0907253674, 0907254154, 0907254318, 0907254523, 0907254719, 0907254846, 0607241461, 0807248702, 0907253682, 0907254155, 0907254320, 0907254534, 0907254720, 0907254847, 0607241469, 0807248739, 0907253692, 0907254156, 0907254322, 0907254567, 0907254721, 0907254849, 0607241473, 0807248916, 0907253700, 0907254157, 0907254326, 0907254584, 0907254722, 0907254850, 0607241475, 0807248937, 0907253717, 0907254158, 0907254330, 0907254588, 0907254725, 0907254851, 0607241591, 0807248945, 0907253724, 0907254159, 0907254332, 0907254614, 0907254726, 0907254854, 0607241595, 0807248947, 0907253725, 0907254160, 0907254334, 0907254618, 0907254727, 0907254856, 0607241597, 0807248997, 0907253728, 0907254161, 0907254336, 0907254622, 0907254728, 0907254860, 0607241605, 0807250127, 0907253732, 0907254162, 0907254338, 0907254624, 0907254729, 0907254862, 0607241866, 0807250131, 0907253734, 0907254164, 0907254339, 0907254629, 0907254730, 0907254864, 0607241868, 0807250133, 0907253736, 0907254168, 0907254340, 0907254631, 0907254731, 0907254866, 0607241872, 0807250137, 0907253738, 0907254177, 0907254341, 0907254633, 0907254732, 0907254868, 0607241878, 0807250143, 0907253740, 0907254178, 0907254342, 0907254635, 0907254733, 0907254870, 0607241880, 0807250149, 0907253763, 0907254180, 0907254343, 0907254636, 0907254734, 0907254871, 0607241882, 0807250150, 0907253773, 0907254181, 0907254357, 0907254637, 0907254735, 0907254872, 0607241884, 0807250151, 0907253783, 0907254182, 0907254359, 0907254639, 0907254736, 0907254873, 0607241886, 0807250153, 0907253790, 0907254184, 0907254360, 0907254640, 0907254737, 0907254874, 0607241888, 0807250155, 0907253798, 0907254186, 0907254362, 0907254641, 0907254738, 0907254875, 0607241890, 0807250156, 0907253800, 0907254188, 0907254367, 0907254642, 0907254739, 0907254877, 0607242129, 0807250157, 0907253818, 0907254190, 0907254368, 0907254644, 0907254740, 0907254878, 0607242133, 0807250161, 0907253822, 0907254192, 0907254369, 0907254646, 0907254741, 0907254879, 0607242135, 0807250164, 0907253824, 0907254194, 0907254370, 0907254647, 0907254747, 0907254880, 0607242139, 0807250172, 0907253830, 0907254197, 0907254372, 0907254648, 0907254748, 0907254881, 0607242141, 0807250174, 0907253838, 0907254198, 0907254373, 0907254649, 0907254749, 0907254883, 0607242149, 0807250178, 0907253842, 0907254202, 0907254374, 0907254651, 0907254750, 0907254884, 0607242166, 0807250182, 0907253848, 0907254204, 0907254375, 0907254652, 0907254751, 0907254885, 0607242168, 0807250190, 0907253896, 0907254206, 0907254376, 0907254656, 0907254753, 0907254886, 0607242170, 0807250192, 0907253897, 0907254208, 0907254377, 0907254658, 0907254754, 0907254887, 0607242172, 0807250200, 0907253898, 0907254210, 0907254378, 0907254660, 0907254755, 0907254888, 0607242377, 0807250207, 0907253900, 0907254212, 0907254379, 0907254661, 0907254756, 0907254889, 0707245469, 0807250246, 0907253908, 0907254214, 0907254380, 0907254662, 0907254757, 0907254891, 0707245624, 0807250248, 0907253909, 0907254216, 0907254381, 0907254663, 0907254758, 0907254893, 0707246066, 0807250256, 0907253910, 0907254230, 0907254382, 0907254664, 0907254759, 0907254895, 0807247650, 0807250260, 0907253912, 0907254232, 0907254384, 0907254665, 0907254760, 0907254897, 0807248038, 0807250278, 0907253913, 0907254234, 0907254386, 0907254666, 0907254761, 0907254899, 0807248041, 0807250282, 0907253933, 0907254236, 0907254388, 0907254667, 0907254762, 0907254922, 0807248075, 0807250286, 0907253938, 0907254240, 0907254390, 0907254668, 0907254765, 0907254924, 0807248077, 0807250288, 0907253940, 0907254242, 0907254398, 0907254669, 0907254767, 1007255202, 0807248097, 0807250290, 0907253943, 0907254244, 0907254400, 0907254670, 0907254769, 1007256655, 0807248099, 0807250292, 0907253944, 0907254246, 0907254402, 0907254671, 0907254771, , 0807248103, 0807250294, 0907253948, 0907254248, 0907254404, 0907254672, 0907254773, , 0807248109, 0807250296, 0907253955, 0907254249, 0907254406, 0907254673, 0907254774, , 0807248121, 0807250302, 0907253961, 0907254250, 0907254408, 0907254674, 0907254775, , 0807248123, 0807250308, 0907253963, 0907254251, 0907254410, 0907254675, 0907254777, , 0807248125, 0807250316, 0907253977, 0907254252, 0907254412, 0907254676, 0907254779, 0807248129, 0807250318, 0907254001, 0907254253, 0907254414, 0907254677, 0907254781, 0807248131, 0807250322, 0907254003, 0907254254, 0907254416, 0907254678, 0907254783, 0807248133, 0807250326, 0907254006, 0907254256, 0907254418, 0907254679, 0907254787, 0807248135, 0807250346, 0907254009, 0907254258, 0907254420, 0907254680, 0907254789, 0807248137, 0807250366, 0907254017, 0907254260, 0907254422, 0907254681, 0907254791, 0807248139, 0807250387, 0907254027, 0907254262, 0907254424, 0907254683, 0907254793, 0807248141, 0807250395, 0907254045, 0907254264, 0907254426, 0907254684, 0907254795, 0807248143, 0807251069, 0907254047, 0907254265, 0907254428, 0907254685, 0907254797, 0807248145, 0907251325, 0907254049, 0907254266, 0907254430, 0907254686, 0907254799, 0807248147, 0907253257, 0907254055, 0907254267, 0907254432, 0907254687, 0907254801, 0807248162, 0907253259, 0907254059, 0907254268, 0907254434, 0907254688, 0907254803, 0807248164, 0907253265, 0907254061, 0907254269, 0907254436, 0907254689, 0907254805, 0807248170, 0907253275, 0907254065, 0907254270, 0907254438, 0907254690, 0907254807, 0807248214, 0907253323, 0907254067, 0907254271, 0907254440, 0907254691, 0907254809, 0807248317, 0907253404, 0907254073, 0907254272, 0907254442, 0907254693, 0907254811, 0807248325, 0907253418, 0907254089, 0907254273, 0907254444, 0907254694, 0907254813, 0807248339, 0907253421, 0907254091, 0907254274, 0907254446, 0907254695, 0907254814, 0807248351, 0907253432, 0907254093, 0907254276, 0907254448, 0907254697, 0907254815, 0807248355, 0907253434, 0907254100, 0907254278, 0907254450, 0907254698, AND 0907254816. M3860A CANADA DISTRIBUTION: 0607240550, 0707243439, 0707243892, 0807246607, 0807246609, 0807246615, 0807246637, 0807248842, 0807248908, 0807248968, 0807249278, 0807249282, 0807249296, 0807250176, 0807250811, 0907253718, 0907253796, 0907254275, 0907254279, 0907254364, 0907254366, 0907254496, 0907254548, 0907254570, AND 0907254610. ============================================= ============================================== 

M3861A CANADA DISTRIBUTION: 0607239912, 0807250320, 0907253701, 0907253726, 0907254023, 0907254105, 0907254141, 0907254153, AND 0907254504. M3860A INTERNATIONAL-NOT INCLUDING CANADA: 0108267591, 0108267701, 0108267705, 0108267715, 0108267723, 0507236763, 0507237318, 0507237325, 0507237333, 0507237369, 0507237377, 0507237391, 0507237393, 0507237409, 0507237410, 0507237460, 0507237504, 0507237506, 0507237527, 0507237547, 0507237551, 0507237668, 0507237676, 0507237778, 0507237803, 0507237805, 0507237808, 0507237824, 0507237826, 0508275018, 0607239952, 0607239954, 0607239956, 0607239958, 0607240008, 0607240013, 0607240021, 0607240029, 0607240037, 0607240039, 0607240043, 0607240045, 0607240047, 0607240049, 0607240051, 0607239952, 0607239954, 0607239956, 0607239958, 0607240008, 0607240013, 0607240021, 0607240029, 0607240037, 0607240039, 0607240043, 0607240045, 0607240047, 0607240049, 0607240051, 0607240105, 0607240167, 0607240171, 0607240205, 0607240259, 0607240272, 0607240306, 0607240316, 0607240318, 0607240320, 0607240322, 0607240323, 0607240332, 0607240334, 0607240346, 0607240356, 0607240360, 0607240365, 0607240370, 0607240372, 0607240374, 0607240376, 0607240380, 0607240809, 0607240811, 0607240864, 0607240878, 0607240880, 0607240882, 0607240886, 0607240904, 0607241005, 0607241471, 0607241876, 0607241894, 0607242365, 0607242466, 0707243291, 0707243340, 0707243399, 0707243444, 0707243838, 0707244007, 0707244013, 0707244020, 0707244024, 0707244039, 0707244041, 0707244044, 0707244399, 0707244405, 0707244408, 0707244483, 0707244485, 0707244493, 0707244503, 0707245561, 0707245706, 0707245707, 0707245708, 0707245712, 0707245714, 0707246252, 0807248019, 0807248023, 0807248053, 0807248055, 0807248061, 0807248072, 0807248078, 0807248119, 0807248127, 0807248204, 0807248216, 0807248224, 0807248228, 0807248232, 0807248236, 0807248244, 0807248255, 0807248259, 0807248261, 0807248263, 0807248265, 0807248269, 0807248271, 0807248273, 0807248275, 0807248277, 0807248283, 0807248285, 0807248287, 0807248289, 0807248291, 0807248293, 0807248297, 0807248302, 0807248307, 0807248345, 0807248347, 0807248367, 0807248369, 0807248420, 0807248422, 0807248424, 0807248428, 0807248430, 0807248434, 0807248436, 0807248438, 0807248440, 0807248446, 0807248452, 0807248462, 0807248464, 0807248478, 0807248488, 0807248668, 0807249047, 0807249063, 0807249204, 0807249276, 0807249303, 0807249601, 0807249605, 0807249609, 0807249611, 0807249614, 0807249615, 0807249616, 0807249617, 0807249619, 0807249620, 0807249621, 0807249623, 0807249624, 0807249626, 0807249627, 0807249628, 0807249630, 0807249632, 0807249633, 0807249634, 0807249635, 0807249636, 0807249637, 0807249638, 0807249639, 0807249640, 0807249641, 0807249642, 0807249643, 0807249645, 0807249646, 0807249647, 0807249648, 0807249649, 0807249652, 0807249655, 0807249659, 0807249672, 0807249674, 0807249676, 0807249681, 0807249685, 0807249688, 0807249689, 0807249699, 0807249749, 0807249802, 0807249804, 0807249807, 0807249816, 0807249818, 0807249822, 0807249828, 0807249830, 0807249834, 0807249836, 0807249844, 0807249866, 0807249868, 0807249870, 0807249872, 0807249874, 0807249876, 0807249882, 0807249886, 0807249888, 0807249890, 0807249892, 0807249894, 0807249901, 0807249903, 0807249904, 0807249905, 0807249907, 0807249911, 0807249912, 0807249913, 0807249915, 0807249917, 0807249919, 0807249921, 0807249925, 0807249933, 0807249935, 0807249937, 0807249957, 0807249977, 0807249979, 0807249981, 0807249995, 0807249999, 0807250077, 0807250116, 0807250168, 0807250170, 0807250187, 0807250218, 0807250560, 0807250562, 0807250590, 0807250647, 0807250651, 0807250913, 0807250927, 0807250943, 0807250945, 0807250947, 0807250955, 0907253219, 0907253245, 0907253251, 0907253262, 0907253267, 0907253269, 0907253271, 0907253272, 0907253278, 0907253280, 0907253281, 0907253283, 0907253319, 0907253321, 0907253325, 0907253327, 0907253394, 0907253794, 0907254025, 0907254131, 0907254146, 0907254235, 0907254237, 0907254287, 0907254419, 0907254654, 0907254742, 0907254746, 0907254766, 0907254782, 0907254788, 0907254794, 0907254896, 0907254906, 0907254908, 0907254912, 0907254914, 0907254916, 0907254960, 0907254964, 0907254966, 0907254968, 0907254970, 0907254971, 0907254999, 0907255003, 0907255007, 0907255013, 0907255028, 0907255045, 0907255057, 0907255061, 0907255065, 0907255067, 0907255069, 0907255071, 0907255073, 0907255077, 0907255081, 0907255085, 0907255087, 0907255089, 0907255091, 0907255095, 0907255108, 0907255110, 0907255113, 0907255116, 0907255118, 0907255120, 0907255121, 0907255122, 0907255136, 0907255141, 0907255163, 0907255165, 1007255210, 1007255218, 1007255231, 1007255233, 1007255237, 1007255241, 1007255243, 1007255249, 1007255267, 1007255271, 1007255301, 1007255303, 1007255305, 1007255307, 1007255313, 1007255317, 1007255319, 1007255323, 1007255371, 1007256663, 1007256675, 1007256677, 1007256679, 1007256681, 1007256683, 1007256704, 1007256767, 1007256773, 1007256777, 1007256781, 1007256787, 1007256793, 1007256795, 1007256799, 1007257012, 1007257014, 1007257016, 1007257063, 1007257071, 1007257073, 1007257006, 1207267451, 1207267455, AND 1207267459.

================================================================= 

M3861A INTERNATIONAL-NOT INCLUDING CANADA: 0108267589, 0507236701, 0507236709, 0507236711, 0507236713, 0507236715, 0507236717, 0507236719, 0507236721, 0507236723, 0507236725, 0507236729, 0507236731, 0507236733, 0507236735, 0507236737, 0507236739, 0507236741, 0507236743, 0507236745, 0507236753, 0507236755, 0507236757, 0507236777, 0507236785, 0507236791, 0507236795, 0507236799, 0507237051, 0507237057, 0507237063, 0507237067, 0507237069, 0507237073, 0507237075, 0507237077, 0507237079, 0507237081, 0507237083, 0507237089, 0507237093, 0507237095, 0507237097, 0507237099, 0507237119, 0507237122, 0507237123, 0507237125, 0507237127, 0507237129, 0507237131, 0507237133, 0507237135, 0507237167, 0507237169, 0507237179, 0507237181, 0507237193, 0507237224, 0507237226, 0507237230, 0507237232, 0507237234, 0507237236, 0507237238, 0507237244, 0507237248, 0507237260, 0507237295, 0507237297, 0507237308, 0507237310, 0507237327, 0507237331, 0507237339, 0507237361, 0507237367, 0507237371, 0507237385, 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1007257360.

======================================= LAERDAL M3840A AND M3841A: 0607240946, 0807246508, 0807249629, 0807249657, 0807249705, 0807249939, 0807249989, 0108267713, 0607240924, 0907253243, 0108267745, 0108267749, 0507237315, 0507237337, 0507237351, 0507237458, 0507237463, 0507237472, 0508275051, 0508275053, 0508275055, 0508275061, 0508275063, 0508275065, 0508275067, 0508275069, 0508275071, 0508275099, 0607240057, 0607240063, 0607240311, 0607240313, 0607240388, 0607240390, 0607240392, 0607240398, 0607240400, 0607240404, 0607240515, 0607240685, 0607240807, 0607240817, 0607240862, 0607240866, 0607240870, 0607240872, 0607240874, 0607240884, 0607240888, 0607240890, 0607240896, 0607240902, 0607240912, 0607240997, 0607240999, 0607241001, 0807248822, 0807248824, 0807248858, 0807248860, 0807248884, 0807248886, 0807248888, 0807248892, 0807248950, 0807248973, 0807248977, 0807248981, 0807248985, 0807248995, 0807248999, 0807249001, 0807249003, 0807249005, 0807249009, 0807249011, 0807249021, 0807249104, 0807249117, 0807249120, 0807249124, 0807249176, 0807249202, 0807249203, 0807249214, 0807249216, 0807249218, 0807249220, 0807249224, 0807249228, 0807249232, 0807249236, 0807249240, 0807249242, 0807249244, 0807249246, 0807249261, 0807249271, 0807249277, 0807249281, 0807249286, 0807249290, 0807249300, 0807249301, 0807249327, 0807250564, 0807250576, 0807250580, 0807250582, 0807250588, 0807250594, 0807250604, 0807250610, 0807250625, 0807250629, 0807250659, 0807250663, 0807250901, 0807250923, 0807250961, 0507236781, 0507236783, 0507237360, 0507237408, 0507237501, 0507237505, 0807248032, 0807248152, 0807248329, 0807248333, 0807248335, 0807248353, 0807248365, 0807248371, 0807248375, 0807248395, 0807248820, 0807248850, 0807248852, 0807248854, 0807248868, 0807248876, 0807248878, 0807248925, 0807248931, 0807248941, 0807248949, 0807248965, 0807248987, 0807249102, 0807249108, 0807249140, 0807249164, 0807249166, 0807249168, 0807249172, 0807249180, 0807249188, 0807249193, 0807249199, 0807249215, 0807249235, 0807249251, 0807249253, 0807249259, 0409300614, 0507237356, 0507237473, 0507237475, 0507237485, 0507237491, 0507237495, 0507237523, 0607240071, 0607241142, 0607241148, 0607241463, 0707243385, 0707243825, 0807248082, 0807248086, 0807248090, 0807248092, 0807248105, 0807248113, 0108267755, 0507237317, 0507237320, 0507237324, 0507237329, 0507237335, 0507237338, 0507237340, 0507237343, 0507237345, 0507237347, 0507237349, 0507237395, 0507237403, 0507237477, 0507237478, 0507237489, 0607238324, 0607239962, 0607239964, 0607240095, 0607240097, 0607240108, 0607240110, 0607240219, 0607240223, 0607240257, 0607240266, 0607240307, 0607240335, 0607240391, 0607240393, 0607240395, 0607240534, 0607240536, 0607241023, 0607241025, 0607241027, 0607241029, 0607241134, 0607241136, 0607241146, 0707243401, 0707243437, 0707243459, 0707243465, 0707243823, 0707243833, 0707243889, 0707243946, 0707243964, 0707243998, 0707244003, 0707244177, 0807248073, 0807248091, 0807248101, 0807248158, 0807248174, 0807248178, 0807248202, 0807248208, 0807248242, 0807248341, 0807248343, 0807248450, 0807248508, 0807248534, 0807248536, 0807248541, 0807248571, 0807248579, 0807248688, 0807248705, 0807248711, 0807248713, 0807248723, 0807248727, 0807248741, 0807248747, 0807248749, 0807248755, 0907253247, 0907253253, 0907253261, 1007257077, 0807250941, 0308273587, 0308273589, 0308273591, 0308273595, 0507237328, 0507237344, 0507237413, 0507237535, 0507237609, 0507237670, 0507237703, 0507237735, 0507237781, 0507237798, 0507237832, 0507237837, 0507237838, 0507237854, 0507237860, 0507237870, 0507237891, 0508275012, 0508275014, 0508275016, 0508275020, 0508275024, 0508275026, 0508275028, 0508275030, 0508275032, 0508275036, 0508275049, 0508275057, 0508275059, 0508275073, 0508275075, 0508275077, 0508275079, 0508275081, 0508275083, 0508275085, 0508275087, 0508275089, 0508275091, 0508275093, 0508275095, 0508275097, 0508275101, 0508275103, 0508275105, 0607238011, 0607238020, 0607238032, 0607238238, 0607238260, 0607238326, 0607238328, 0607238647, 0607238657, 0607238661, 0607238675, 0607238679, 0607238687, 0607238691, 0607238693, 0607238699, 0607239001, 0607239187, 0607239960, 0607240009, 0607240011, 0607240017, 0607240019, 0607240141, 0607240153, 0607240155, 0607240159, 0607240161, 0607240165, 0607240169, 0607240181, 0607240310, 0607240340, 0607240813, 0607240825, 0607240827, 0607240829, 0607240831, 0607240833, 0607240835, 0607240843, 0607240855, 0607240857, 0607240861, 0607240881, 0607240898, 0607240900, 0607240926, 0607240930, 0607240932, 0607240936, 0607240938, 0607240940, 0607240952, 0607240956, 0607240958, 0607240960, 0607240962, 0607240966, 0607240968, 0607240970, 0707244715, 0707244824, 0707244830, 0707244832, 0707244870, 0707244894, 0707244904, 0807249941, 0807249945, 0907252534, 0507237736, 0807248674, 0807248906, 0807248943, 0807249015, 0807249085, 0807249087, 0807249095, 0807249625, 0807249631, 0807249644, 0807249654, 0807249656, 0807249660, 0807249677, 0807249679, 0807249694, 0807249703, 0807249769, 0807249771, 0807249906, 0807249908, 0807249927, 0807249958, 0807249959, 0807249961, 0807249975, 0807249983, 0807249985, 1207267284, 0507237741, 0507237777, 0507237841, 0507237883, 0607238242, 0607238244, 0707244856, 0707244878, 0508275047, 0607240061, 0607240394, 0607240396, 0607241032, 0607241038, 0707243381, 0707243383, 0707243422, 0707243432, 0707243433, 0707243460, 0707243467, 0707243855, 0707243865, 0707243877, 0707243879, 0707243881, 0707243885, 0707243890, 0707243896, 0707244864, 0807250528, 0807250538, 0807250540, 0807250572, 0807250574, 0807250637, 0807250848, 0807250907, 0907254015, 0907254752, 0907254764, 0907254768, 0907254770, 0907254776, 0907254784, 0907254786, 0907254790, 0907254792, 0907254796, 0907254798, 0907254800, 0907254834, 0907254882, 0907254890, 0907254894, 0907254898, 0907254902, 0907254904, 0907254932, 0907254934, 0907254936, 0907254938, 0907254940, 0907254942, 0907254944, 0907254946, 0907254948, 0907254950, 0907254952, 0907254954, 0907254956, 0907254958, 0907254962, 0907254972, 0907254974, 0907254976, 0907254978, 0907254980, 0907254982, 0907254984, 0907254988, 0907254990, 0907254992, 0907254994, 0907254996, 0907254998, 0907255000, 0907255001, 0907255005, 0907255009, 0907255011, 0907255017, 0907255026, 0907255039, 0907255047, 0907255049, 0907255051, 0907255053, 0907255055, 0907255059, 0907255063, 0907255079, 0907255093, 0907255101, 0907255103, 0907255104, 0907255105, 0907255107, 0907255109, 0907255111, 0907255112, 0907255114, 0907255115, 0907255119, 0907255123, 0907255124, 0907255125, 0907255128, 0907255129, 0907255130, 0907255131, 0907255132, 0907255133, 0907255134, 0907255161, 0108269537, 0507237595, 0507237603, 0507237620, 0507237687, 0507237691, 0507237702, 0507237747, 0507237751, 0507237793, 0507237795, 0507237811, 0507237835, 0507237843, 0507237845, 0507237847, 0507237884, 0507237886, 0507237922, 0507237924, 0507237933, 0507237938, 0507237948, 0507238000, 0507238005, 0607238012, 0607238014, 0607238017, 0607238018, 0607238019, 0607238021, 0607238035, 0607238046, 0607238059, 0607238060, 0607238070, 0607238083, 0607238094, 0607238096, 0607238427, 0607239344, 0607239346, 0607239406, 0607239414, 0607239508, 0607242373, 0607242375, 0707243436, 0707243438, 0707243442, 0707243813, 0707243856, 0707243864, 0707243898, 0807247353, 0807247355, 0807248393, 0807248898, 0807248903, 0807248904, 0807248909, 0807248910, 0807248915, 0807248918, 0807248928, 0807248929, 0807248936, 0807248939, 0807248942, 0807248946, 0807248951, 0807248953, 0807248954, 0807248955, 0807248956, 0807248957, 0807248959, 0807248960, 0807248963, 0807248966, 0807248970, 0807248976, 0807248983, 0807248991, 0807248993, 0807249007, 0807249178, 0807249182, 0807249184, 0807249186, 0807249190, 0807249208, 0807249209, 0807249210, 0807249211, 0807249212, 0807249213, 0807249219, 0807249221, 0807249222, 0807249223, 0807249229, 0807249230, 0807249233, 0807249234, 0807249238, 0807249248, 0807249250, 0807249252, 0807249254, 0807249256, 0807249260, 0807249263, 0807249264, 0807249265, 0807249266, 0807249268, 0807249269, 0807249274, 0807249275, 0807249279, 0807249283, 0807249285, 0807249287, 0807249288, 0807249289, 0807249291, 0807249292, 0807249293, 0807249295, 0807249297, 0807249298, 0807249299, 0807250840, 0907253246, 0907253248, 0907253250, 0907253252, 0907253254, 0907253256, 0907253258, 0907253260, 0907253266, 0907253268, 0907253270, 0907253274, 0907253276, 0907253282, 0907253288, 0907253292, 0907253294, 0907253296, 0907253298, 0907253300, 0907253302, 0907253304, 0907253306, 0907253310, 0907253312, 0907253314, 0907253316, 0907253318, 0907253320, 0907253322, 0907253324, 0907253326, 0907253328, 0907253330, 0907253331, 0907253332, 0907253333, 0907253334, 0907253335, 0907253336, 0907253338, 0907253339, 0907253340, 0907253341, 0907253342, 0907253388, 0907253390, 0907253392, 0907253396, 0907253405, 0907253415, 0907253417, 0907253419, 0907253423, 0907253433, 0907253439, 0907253443, 0907253445, 0907253459, 0907253461, 0907253465, 0907253467, 0907253469, 0907253471, 0907253473, 0907253479, 0907253481, 0907253483, 0907253501, 0907253505, 0907253509, 0907253511, 0907253517, 0907253521, 0907253523, 0907253525, 0907253543, 0907253547, 0907253555, 0907253597, 0907253599, 0907254013, 0607239913, 0607240402, 0807246506, 0907253217, 0907253277, 1007257075, 0308273599, 0507237326, 0507237366, 0507237499, 0507237950, 0508275022, 0607238649, 0607238682, 0607239903, 0607239905, 0607240023, 0607240033, 0607240147, 0607240149, 0607240157, 0607240195, 0607240197, 0607240201, 0607240350, 0807248042, 0807248050, 0807248305, 0807249622, 0807249993, 0908288146, 0908288152, 0607240928, 0607240944, 0108267577, 0108267709, 0108267739, 0108267743, 0108267753, 0507237195, 0507237197, 0507237199, 0507237330, 0507237358, 0507237373, 0507237375, 0507237433, 0507237444, 0507237450, 0507237481, 0507237493, 0607240059, 0607240065, 0607240067, 0607240069, 0607240099, 0607240136, 0607240138, 0607240309, 0607240329, 0607240333, 0607240337, 0607240359, 0607240361, 0607240367, 0607240382, 0607240384, 0607240659, 0607240667, 0608278912, 0807246502, 0807246621, 0807246639, 0807246641, 0807246643, 0807248685, 0807248744, 0807248772, 0807248818, 0807248834, 0807248847, 0807248872, 0807248880, 0807248882, 0807248890, 0807248919, 0807249125, 0807249146, 0807249152, 0807249154, 0807249156, 0807249174, 1207267276, 1207267280, 1207267282, 1207267286, 1207267290, 1207267292, 1207267294, 1207267296, 1207267298, 1207267409, 1207267411, 1207267415, 1207267419, 1207267441, 1207267449, 1207267453, 1207267457, 1207267463, 1207267465, 1207267471, 0807248927, 0807249701, 0807249923, 0907253244, 0907253255, 0907253286, 0907253403, 0807249267, AND 0807249273;

2) The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Seattle, WA, 
A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
VOLUME OF PRODUCT IN COMMERCE
5808 units
DISTRIBUTION Nationwide, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates

PRODUCT Guider XF Softip Guide Catheter. The device is intended to facilitate placement of interventional devices into the neurovascular system. UPN/Model numbers: H965100420/10042, H965100430/10043, H965100440/10044, H965100460/10046, H965100470/10047, H965100480/10048, H965100500/10050, H965100510/10051, H965100520/10052, M003100620/10062, M003100630/10063, M003100640/10064, M003101420/10142, M003101430/10143, M003101440/10144, M003101460/10146, M003101470/10147, M003101480/10148, M003101500/10150, M003101510/10151, M003101520/10152, M003101620/10162, M003101630/10163 and M003101640/10164. 
CODE Batch numbers numerous. Please contact Boston Scientific Corporation for specific lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Fremont, CA, 
Manufacturer: Boston Scientific Corp., Maple Grove, MN. 
REASON
Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
VOLUME OF PRODUCT IN COMMERCE
94,296 units
DISTRIBUTION Nationwide, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, UAE, Uruguay, Venezuela, Vietnam and Yemen

PRODUCT Coloplast Titan OTR Inflatable Penile Prosthesis, 18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis. CODE Lot 1919244
RECALLING FIRM/MANUFACTURER
Coloplast Manufacturing, US, LLC, Minneapolis, MN
REASON
Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the product has been manufactured utilizing identical materials and processes compared to the existing Titan OTR pumps.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION Nationwide

PRODUCT Apligraf (draftskin) packaging. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers. 
CODE Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73
RECALLING FIRM/MANUFACTURER
Organogenesis, Inc., Canton, MA
REASON
Unit contaminated with Staphylococcus epidermidis.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION Nationwide

PRODUCT Siregraph CF X-Ray System, Model Number: 4466033. Intended use: X-Ray, Fluoroscopic, Image-intensified. 
CODE Serial Numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. 
REASON
Possible injury to hand/fingers.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION Nationwide

PRODUCT
NOVEL SPINAL SPACER SYSTEM, Part Number(s): 

a) 64817-010, b) 64817-012, c) 64817-013, d) 64817-014, e) 64817-107, f) 64113-012, g) 64113-010, h) 64765-109, i) 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology. 
CODE
a) Lot Number(s): 623549; b) Lot Number(s): 623551; c) Lot Number(s): 623552; d) Lot Number(s): 623553; e) Lot Number(s): 623584; f) Lot Number(s): 623619; g) Lot Number(s): 623620; h) Lot Number(s): 623909; i) Lot Number(s): 623778
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA
REASON
Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
VOLUME OF PRODUCT IN COMMERCE
37 devices
DISTRIBUTION Nationwide

PRODUCT
1) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. 

2) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. 

3) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. 

4) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. 
CODE
1) Lot: 11637077, 11676784, 11740302, 11811184, 11864634, 11889228, 11960754, 12043982, 12156054, 12170193, 12240685, 12240686, 12311172, 12363749, 12397168, 12397177, 12442594, 12442595, 12490333, 12512652, 12530896, 12535289, 12535290, 12556163, 12567338, 12567339, 12582186, 12603422, 12605776, 12652788, 12652791, 12720339;

2) Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334;

3) Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947;  

4) Lot: 12156055, 12186592, 12186593, 12186594, 12186596, 12186599, 12227670, 12227671, 12274315, 12303573, 12322322, 12330756, 12330757, 12331003, 12331005, 12331006, 12331007, 12331008, 12368967, 12379423, 12383688, 12397162, 12442599, 12442640, 12442780, 12459665, 12459666, 12526737, 12535281, 12535282, 12535283, 12535284, 12582188, 12605774, 12617283, 12687684, 12702148, 12702149, 12702553
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
Manufacturer: Boston Scientific Cork, Ltd, Cork, Ireland. 
REASON
Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
VOLUME OF PRODUCT IN COMMERCE
9,800 units
DISTRIBUTION Nationwide, Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates

PRODUCT 
1) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-09 The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

2) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

3) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

4) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

5) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 19 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

6) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

7) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

8) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

9) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

10) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

11) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

12) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

13) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

14) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

15) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left,19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

16) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

17) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

18) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

19) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

20) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

21) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile; REF 00-5424-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

22) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

23) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

24) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

25) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

26) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

27) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

28) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

29) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

30) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

31) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

32) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

33) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

34) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

35) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

36) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

37) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

38) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

39) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

40) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

41) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

42) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

43) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile;  REF 00-5428-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

44) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

45) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

46) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

47) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

48) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

49) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

50) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

51) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

52) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

53) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

54) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

55) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

56) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

57) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

58) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

59) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 

60) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. 
CODE

1)  Lots: 60930892, 60947723, 60954146, 60954147, 60958265, 60958284, 60988214, 61001538, 61005431, 61012248, 61023607, 61027911, 61036361, 61045090, 61058607, 61064796, 61069402, 61075249, 61085866, 61091187, 61096344, 61101443, 61114171 and 61136939;

2) Lots: 60930893, 60947729, 60954138, 60954148, 60958267, 60964475, 60971780, 60987831, 60992913, 61001539, 61005445, 61023608, 61036333, 61036334, 61036362, 61058581, 61058608, 61069403, 61075250, 61085867, 61091188, 61096345, 61101444 and 61114172;

3) Lots: 60943097, 60943098, 60958268, 60964476, 60971781, 60988215, 60992914, 60992915, 61001540, 61005432, 61012249, 61036335, 61036336, 61036363, 61058609, 61064797, 61069404, 61075251, 61085868, 61091189, 61101445 and 61114161;

4) Lots 60943101, 60964477, 60971773, 60971774, 60971776, 60971782, 60988217, 60992916, 60992917, 60992918, 61001541, 61005446, 61017689, 61036337, 61036364, 61051466, 61058610, 61069405, 61075252, 61085869, 61091190, 61096346, 61106547 and 61157808;

5) Lots 61078741 and 61157812;

6) Lots 60947730, 60954139, 60954149, 60954312, 60954313, 60964478, 60975030, 60981786, 60981799, 60987818, 60987832, 60988218, 60992919, 60992920, 60992922, 61001542, 61001543, 61005433, 61005447, 61017690, 61023609, 61027913, 61027914, 61036365, 61036366, 61045091, 61051467, 61058611, 61064798, 61069406, 61075235, 61078742, 61078743, 61085870, 61091175, 61091191, 61096347, 61101446, 61101447, 61101448, 61106548, 61114162, 61114173, 61117029, 61117030, 61117031, 61117032, 61117043, 61117049, 61126520 and 61126521;

7) Lots 60916390, 60916392, 60916393, 60916424, 60930896, 60947731, 60954140, 60954150, 60958269, 60964459, 60964479, 60981787, 60981801, 60987819, 60987833, 60987834, 60992923, 60992924, 61001544, 61005434, 61005448, 61023610, 61027878, 61036338, 61036367, 61036368, 61051468, 61064799, 61069407, 61075236, 61078744, 61078745, 61091176, 61091192, 61091193, 61101449, 61101450, 61106550, 61114163, 61114174, 61117033, 61117050 and 61122282;

8) Lots 60911931, 60916425, 60930897, 60947732, 60954151, 60958261, 60958270, 60964480, 60975032, 60981788, 60981803, 60988219, 60992925, 60992926, 60992927, 61001545, 61023593, 61023594, 61027879, 61036339, 61036369, 61051469, 61064801, 61069408, 61075237, 61078746, 61091177, 61096348, 61096349, 61101451, 61106551, 61114175 and 61117044;

9) Lots 60943103, 60954152, 60964460, 60975017, 60975018, 60975033, 60980756, 60980757, 60980758, 60981804, 60992928, 60992929, 60993907, 60993908, 61017691, 61036340, 61036371, 61051470, 61064802, 61069409, 61078747, 61078748, 61091178, 61096350, 61101452 and 61114176;

10) Lot 61139728;

11) Lots 60911919, 60911932, 60916426, 60930898, 60947734, 60954141, 60954142, 60954153, 60958271, 60964481, 60981789, 60981805, 60987820, 60988220, 60992930, 60992931, 60992932, 61001546, 61017692, 61023595, 61023611, 61027915, 61036373, 61045092, 61045093, 61064803, 61069410, 61075238, 61078749, 61091179, 61091180, 61096351, 61101453, 61101454, 61106552, 61114177, 61117034, 61117045, 61122283 and 61136935;

12) Lots 60911920, 60911933, 60916427, 60930899, 60947724, 60954154, 60958272, 60964461, 60964482, 60981790, 60981806, 60987821, 60987835, 60992933, 60992934, 61001547, 61001548, 61023596, 61023612, 61036342, 61045076, 61051471, 61058582, 61064804, 61069411, 61078750, 61078751, 61096352, 61096353, 61101455, 61106553, 61114164, 61117035 and 61136934;

13) Lots 60943105, 60943106, 60954155, 60958273, 60975034, 60981807, 60987822, 60988221, 60992935, 60992936, 61001549, 61017693, 61027881, 61036343, 61045077, 61051472, 61064805, 61069412, 61075239, 61078752, 61091181, 61096354, 61101456, 61106554 and 61136936;

14) Lots 60930889, 60933722, 60933723, 60943107, 60943108, 60975019, 60980759, 60980760, 60980761, 60981791, 60981808, 60992937, 60992938, 61001550, 61017694, 61027882, 61036344, 61045078, 61051473, 61069413, 61069419, 61078753, 61091182, 61096355, 61101457 and 61106555;

15) Lots 61096356 and 61157824;

16) Lots 60943109, 60943110, 60947725, 60954156, 60958274, 60971777, 60971783, 60988222, 60992939, 61001551, 61005435, 61012256, 61017695, 61027916, 61045079, 61051474, 61058612, 61058613, 61069414, 61075253, 61085871, 61091194, 61096357, 61106556, 61114165, 61114178 and 61136937;

17) Lots 60911923, 60930902, 60947736, 60954143, 60954157, 60958275, 60958276, 60971778, 60971784, 60987836, 60992940, 60992941, 61005436, 61012257, 61017696, 61023613, 61045080, 61051475, 61058614, 61058615, 61075240, 61075254, 61085872, 61091195, 61096358, 61106557 and 61114184;

18) Lots 60958277, 60964462, 60971779, 60971785, 60987837, 60992942, 60992943, 61001552, 61012258, 61017697, 61023614, 61036345, 61045081, 61058616, 61058617, 61075241, 61078754, 61085873, 61091196, 61106558, 61114166 and 61117051;

19) Lots 60943113, 60943114, 60971772, 60971775, 60971786, 60987823, 60988224, 60992944, 60992945, 60992946, 61005437, 61017698, 61023615, 61036346, 61045082, 61051476, 61058618, 61058619, 61078755, 61085874, 61091197, 61096359, 61106559 and 61114185;

20) Lots 61085875 and 61157831;

21) Lots 60930904, 60943115, 60943116, 60947738, 60954144, 60954158, 60958278, 60964463, 60964464, 60964465, 60975020, 60975035, 60981792, 60981809, 60987824, 60987825, 60988225, 60992947, 60992948, 60992949, 60992950, 60992951, 60992952, 60992953, 60993909, 60993910, 61005438, 61017699, 61023597, 61023616, 61027883, 61027917, 61036347, 61045083, 61051477, 61051478, 61058583, 61064806, 61069415, 61075242, 61078756, 61078757, 61085876, 61091183, 61096360, 61096361, 61101458, 61101459, 61106560, 61106561, 61106562, 61114167, 61114179, 61117036, 61117037, 61117038, 61117046, 61117052, 61122284, 61122285, 61126522 and 61126523;

22) Lots 60916402, 60930905, 60932814, 60932815, 60947739, 60954159, 60958279, 60964466, 60964467, 60975036, 60975042, 60981810, 60987826, 60987838, 60992954, 60992955, 60992956, 60992957, 60992958, 60993931, 61005439, 61017700, 61023598, 61027884, 61036348, 61036349, 61045084, 61051479, 61058584, 61069416, 61069420, 61075243, 61078758, 61085877, 61091184, 61096362, 61101460, 61101461, 61106563, 61106564, 61114180, 61117039, 61117047, 61126524 and 61126525;
 
23) Lots 60932817, 60947726, 60947740, 60954160, 60958280, 60964468, 60975037, 60981811, 60987827, 60988226, 60992959, 60992960, 60992961, 61001553, 61005440, 61017701, 61027885, 61036350, 61036354, 61045085, 61051480, 61064807, 61069417, 61075244, 61078759, 61085878, 61096363, 61101462, 61106565, 61114168 and 61117040;

24) Lots 60932819, 60954145, 60958262, 60964470, 60975021, 60975022, 60975038, 60975043, 60980762, 60980763, 60980764, 60981812, 60992962, 60993933, 60993934, 61017702, 61017703, 61036355, 61045086, 61051481, 61064808, 61069418, 61078760, 61085879, 61096364, 61101463, 61106566 and 61114181;

25) Lots 61096365 and 61139734;

26) Lots 60932820, 60932821, 60943117, 60943118, 60947727, 60958263, 60958281, 60964471, 60975039, 60975044, 60981813, 60987828, 60988227, 60992963, 60992964, 60992965, 60992966, 61001554, 61005441, 61017704, 61023599, 61027887, 61027918, 61036356, 61051482, 61051483, 61064809, 61064810, 61075245, 61078761, 61085880, 61091185, 61096366, 61101464, 61106567, 61106568, 61114169, 61117041, 61117042, 61117053, 61122286 and 61136938;

27) Lots 60943119, 60943120, 60958264, 60958282, 60964472, 60964473, 60975046, 60981814, 60987829, 60987839, 60992967, 60992968, 60992969, 60992970, 61001555, 61005442, 61017705, 61027888, 61036357, 61036358, 61045087, 61051484, 61064811, 61064812, 61075246, 61078762, 61085881, 61096367, 61101465, 61106569, 61106570, 61114182, 61117048 and 61122287;

28) Lots 60943121, 60943122, 60958283, 60964474, 60975047, 60981815, 60987830, 60992971, 60992972, 60992973, 61005443, 61023601, 61027889, 61036359, 61045088, 61058585, 61064813, 61064814, 61075247, 61078763, 61085882, 61096368, 61101466, 61106571 and 61114183;

29) Lots 60975024, 60975025, 60975040, 60980765, 60980766, 60980767, 60992974, 60992975, 60992976, 61005444, 61017706, 61027890, 61036360, 61045089, 61058586, 61064815, 61075248, 61085883, 61091186, 61096369, 61106572 and 61114170;

30) Lots 61101467 and 61157838;

31) Lots 60947756, 60947758, 60954113, 60954115, 60954128, 60958287, 60958296, 61017813, 61017834, 61036377, 61036391, 61045095, 61058621, 61058645, 61065051, 61069421, 61075283, 61078795, 61091198, 61091206, 61101468, 61106574, 61106603, 61117054 and 61136943;

32) Lots 60943126, 60947745, 60947759, 60947760, 60947761, 60954116, 60954129, 60958288, 60958297, 60987857, 60992977, 61001556, 61005450, 61012266, 61023686, 61023687, 61036392, 61058622, 61058623, 61058646, 61075257, 61075284, 61085884, 61091207, 61091208, 61101469, 61106575, 61114187, 61126528 and 6136944;

33) Lots 60954130, 60958298, 60964493, 60971787, 60988242, 60992978, 60992979, 60992980, 61005451, 61012267, 61023688, 61023689, 61036393, 61058624, 61058647, 61065052, 61075258, 61075285, 61085885, 61091209, 61096370, 1101470 and 61106604;

34) Lots 60958299, 60971788, 60971789, 60971790, 60981860, 60987840, 60992981, 60992982, 60992983, 60992984, 61001557, 61012268, 61023690, 61023691, 61036394, 61045096, 61058648, 61065053, 61075259, 61075286, 61085886, 61091210, 61096371, 61101471 and 61117055;

35) Lots 60943132, 60958301, 60971791, 60971792, 60971793, 60987841, 60988243, 60992985, 60992986, 60992987, 61012269, 61017814, 61023692, 61036395, 61045097, 61058625, 61058649, 61065054, 61075287, 61085887, 61091211, 61101472 and 61106605;

36) Lots 60947746, 60947747, 60947762, 60947763, 60947764, 60947765, 60947766, 60947767, 60954117, 60954118, 60954131, 60958289, 60958302, 60975048, 60975049, 60987858, 60987859, 60992988, 60992989, 61001558, 61005452, 61005453, 61017815, 61017835, 61027919, 61027920, 61036396, 61036397, 61045098, 61045099, 61045101, 61045102, 61058626, 61065055, 61069422, 61069423, 61069442, 61075260, 61078764, 61078765, 61078796, 61091199, 61091201, 61096372, 61096373, 61101473, 61101474, 61101475, 61114188, 61114189, 61114190, 61117056, 61117057, 61117058, 61117059, 61117060, 61126529, 61126555 and 61139735;

37) Lots 60941610, 60941611, 60947748, 60947768, 60947769, 60947770, 60947771, 60947772, 60954114, 60954119, 60954132, 60958290, 60958303, 60964494, 60975050, 60975051, 6981862, 60987842, 60987860, 60987861, 60992990, 60992991, 60992992, 60992994, 61001559, 61001560, 61005454, 61005455, 61017816, 61027921, 61027922, 61036378, 61036398, 61036399, 61045103, 61045104, 61058628, 61058629, 61065056, 61069424, 61075261, 61078766, 61078767, 61085888, 61085889, 61091212, 61096374, 61096375, 6101476, 61101477, 61101478, 61106576, 61114191, 61114192, 61117061, 61117062, 61122288, 61126530 and 61126531;

38) Lots 60947749, 60947773, 60947774, 60954120, 60954133, 60958291, 60958304, 60964495, 60975052, 60975054, 60981864, 60987843, 60987862, 60992995, 60992996, 60992997, 60992998, 60992999, 60993001, 61001561, 61005456, 61017817, 61027924, 61027926, 61027928, 61036401, 61036402, 61045105, 61058630, 61065057, 61069425, 61075262, 61078768, 61078769, 61085890, 61096376, 61096377, 61096378, 61101479, 61101480, 61114193, 61114194, 61117063, 61117064 and 61122289;

39) Lots 60941616, 60964484, 60964496, 60975055, 60975057, 60975059, 60980768, 60980769, 60980770, 60981866, 60993002, 60993003, 60993004, 61005457, 61017818, 61027930, 61027932, 61036406, 61036407, 61058631, 61058632, 61065058, 61069426, 61078770, 61085891, 61085892, 61096379, 61101481, 61101482, 61114195 and 61117065;

40) Lots 60958305, 60964497, 60975060, 60975061, 60980771, 60980772, 60980773, 60981868, 60993005, 60993006, 61001562, 61023693, 61027934, 61036408, 61045106, 61051488, 61065059, 61069427, 61078771, 61091202, 61096380, 61101483 and 61114196;

41) Lots 60932788, 60937764, 60937765, 60958306, 60981870, 60988244, 60993007, 60993008, 60993009, 61001563, 61005458, 61017819, 61017836, 61036379, 61036409, 61045107, 61045108, 61051489, 61065060, 61069428, 61069443, 61075263, 61078772, 61078797, 61096381, 61096382, 61101484, 61106577, 61114197, 61114198, 61117066, 61122290, 61126556 and 61136945;

42) Lots 60937767, 60958307, 60964498, 60981872, 60987863, 60993010, 60993011, 60993012, 60993013, 61001564, 61005459, 61017820, 61027936, 61036380, 61036410, 61045109, 61051490, 61065061, 61069429, 61075264, 61078773, 61085893, 61096383, 61096384, 61101485, 61106579, 61114199, 61117067, 61117068 and 61136946;

43) Lots 60937769, 60964499, 60981874, 60987844, 60988245, 60993014, 60993015, 60993016, 60993017, 61005460, 61005461, 61017821, 61036381, 61036382, 61036411, 61051491, 61058633, 61065062, 61075265, 61078774, 61085894, 61096385, 61096386, 61101486, 61106580, 61114201 and 61117069;

44) Lots 60943133, 60943134, 60975062, 60981875, 60987845, 60993018, 60993019, 60993020, 60993021, 61001565, 61023694, 61027938, 61027940, 61036383, 61036412, 61045110, 61051492, 61065063, 61069430, 61078775, 61085895, 61096387, 61096388, 61106581, 61114202 and 60937774;

45) Lots 60975063, 60975064, 60980774, 60980775, 60980776, 60993022, 60993023, 60993024, 61023695, 61027941, 61036384, 61036413, 61051493, 61058634, 61065064, 61075266, 61078776, 61096389, 61096390, 61106582 and 61114203;

46) Lots 60954121, 60954122, 60954134, 60958308, 60971794, 60988246, 60993025, 61001566, 61005462, 61017822, 61023696, 61036414, 61045111, 61051494, 61065065, 61069431, 61075267, 61075288, 61085896, 61091213, 61091214, 61101487, 61106583, 61114216 and 61126557;

47) Lots 60943136, 60954123, 60954135, 60958292, 60958309, 60971795, 60987864, 60993026, 60993027, 61005463, 61012279, 61017823, 61023697, 61036415, 61045112, 61051495, 61065066, 61069432, 61075268, 61075289, 61085897, 61091215, 61091216, 61101488, 61106606, 61114217 and 61136947;

48) Lots 60947751, 60930884, 60947776, 60954124, 60954136, 60958310, 60964501, 60971796, 60988248, 60993028, 60993029, 60993030, 61001567, 61005464, 61012280, 61023698, 61023699, 61036416, 61045113, 61051496, 61065067, 61075269, 61078777, 61085898, 61091217, 61096391, 61101489, 61106607 and 61114218;

49) Lots 60971797, 60971801, 60981877, 60987846, 60988249, 60993031, 60993032, 60993033, 60993034, 61001568, 61012281, 61017824, 61023701, 61036417, 61045114, 61051497, 61065068, 61069433, 61078778, 61085899, 61091218, 61091219, 61101490 and 61114204;

50) Lots 60943140, 60964502, 60971798, 60971799, 60981879, 60987847, 60993035, 60993036, 60993037, 60993038, 61012282, 61017825, 61023702, 61036418, 61045115, 61051498, 61065069, 61075270, 61078779, 61091220, 61096392 and 61106584;

51) Lots 60942684, 60942685, 60942686, 60947752, 60954125, 60954137, 60958311, 60964485, 60964486, 60964503, 60975065, 60981881, 60981883, 60987848, 60987849, 60988250, 60993039, 60993040, 60993041, 60993042, 60993043, 60993044, 60993045, 61001569, 61005465, 61005466, 61017826, 61017837, 61027942, 61027943, 61027944, 61036419, 61036420, 61045116, 61045117, 61051499, 61058635, 61058636, 61065070, 61069434, 61069435, 61069444, 61075271, 61078780, 61078781, 61085901, 61091203, 61091221, 61091222, 61096393, 61101491, 61106585, 61106586, 61106587, 61114205, 61114206, 61117070, 61117071, 61117072, 61117073, 61122291, 61122292, 61126550 and 61126558;

52) Lots 60930886, 60942687, 60942688, 60942689, 60954126, 60958293, 60958312, 60964487, 60964488, 60964489, 60964504, 60975066, 60975067, 60980777, 60980778, 60980779, 60981884, 60981886, 60993046, 60993047, 60993048, 60993049, 60993050, 60993051, 60993052, 61001570, 61001571, 61005467, 61005468, 61017827, 61027945, 61036385, 61036386, 61036421, 61036422, 61051501, 61051503, 61058637, 61065071, 61069436, 61069437, 61075272, 61078782, 61078783, 61085902, 61085903, 61091223, 61096394, 61101492, 61101493, 61106588, 61106589, 61114207, 61114208, 61117074, 61117075, 61117076, 61117077, 61122293 and 61122294;

53) Lots 60942691, 60942692, 60947753, 60954127, 60958294, 60958313, 60964490, 60964491, 60964505, 60981888, 60981890, 60987850, 60987851, 60988251, 60993053, 60993054, 60993055, 60993056, 60993057, 60993058, 61001572, 61001573, 61005469, 61017828, 61023703, 61027946, 61036387, 61036423, 61036424, 61051504, 61051505, 61051506, 61065072, 61069438, 61075273, 61078784, 61078785, 61085904, 61091224, 61096395, 61096396, 61101494, 61106590, 61106591, 61114209, 61117078, 61117079 and 61122295;

54) Lots 60942694, 60942695, 60964506, 60975068, 60975069, 60980780, 60980781, 60980782, 60981891, 60981892, 60981893, 60993059, 60993060, 60993061, 61001574, 61017829, 61023704, 61036388, 61036425, 61036426, 61051507, 61051508, 61065073, 61069439, 61078786, 61085905, 61091204, 61091225, 61101495, 61106592, 61114210 and 61117080;

55) Lots 60942696, 60942697, 60942698, 60975071, 60980783, 60980784, 60980785, 60981894, 60993062, 60993063, 60993064, 61001575, 61017830, 61023705, 61036389, 61036427, 61051509, 61065074, 61069440, 61078787, 61085906, 61091226, 61106593 and 61114211;

56) Lots 60937775, 60937776, 60964507, 60981895, 60987852, 60987853, 60988252, 60993065, 60993066, 60993067, 60993068, 61001576, 61005470, 61005471, 61017831, 61027947, 61027948, 61036428, 61036429, 61051510, 61058639, 61069441, 61069445, 61075274, 61078788, 61078789, 61085907, 61091227, 61096397, 61096398, 61106594, 61106595, 61114212, 61117081, 61117082, 61126551, 61136941 and 61136948;

57) Lots 60964492, 60964508, 60981896, 60987854, 60987855, 60987865, 60993069, 60993070, 60993071, 60993072, 61001577, 61005472, 61023707, 61023708, 61027949, 61036430, 61051511, 61051512, 61058640, 61069446, 61075275, 61075276, 61078790, 61085908, 61091228, 61096399, 61101496, 61106596, 61114213, 61117083, 61122296 and 61136949;

58) Lots 60933716, 60933717, 60964509, 60981897, 60987856, 60988253, 60993073, 60993074, 60993075, 61001578, 61005473, 61023710, 61027950, 61027951, 61045118, 61051513, 61058641, 61058642, 61075277, 61075278, 61078791, 61085909, 61091205, 61091229, 61096401, 61106597, 61106598, 61114214, 61122297 and 61136942;

59) Lots 60933719, 60975072, 60975073, 60975074, 60975075, 60980786, 60980787, 60980788, 60980789, 60980790, 60981898, 61001579, 61017832, 61023712, 61027952, 61045119, 61051514, 61058643, 61065075, 61075279, 61075280, 61078792, 61085910, 61091230, 61101497, 61106599, 61114215 and 61136950;

60) Lots 60943141, 60943142, 60975076, 60980791, 60980792, 60980793, 60981899, 60993076, 60993077, 61017833, 61023713, 61036390, 61045120, 61051515, 61065076, 61075281, 61075282, 61078793, 61091231, 61101498, 61106601 and 61117084
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN,
REASON
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
VOLUME OF PRODUCT IN COMMERCE
26,404 units
DISTRIBUTION Nationwide, Austria, Belgium, France, Germany, Japan, Spain, Switzerland

PRODUCT
1) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170. Catalog Numbers: 882390 and 882410. 

2) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640; Catalog Numbers: 882470, 882471, and 882473. 
CODE
1) Serial Numbers: 4190 and 4191;
2) Serial Numbers: 7096, 7139, 7144, 7145, 7146, 7148, 7149, 7150, and 7151
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, 
REASON
Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION OH, GA, MI, CA, Germany, France Japan, and South Korea

PRODUCT Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, and F12-345-425NS. 
CODE All lot and serial numbers are being recalled.
RECALLING FIRM/MANUFACTURER
Orthofix, Inc., McKinney, TX,
REASON
ISKD lengthening device has the potential for not pre-distracting.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION FL, MD, TN, OH, NY, CA, GA, Mexico Italy, Canada

PRODUCT  Norian CRS Rotary Mixer Cement 10cc sterile. Catalog number 614.10.01S. 
CODE Lot number N996352
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, 
REASON
Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength includes extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION CO, KS, MA, MO, NY, SC, TX, UT, WA

PRODUCT  Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers. 
CODE Lot 087190
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, 
REASON
Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION FL, PA

PRODUCT 
1) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02. 

2) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02. 
CODE All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster, Inc., Chihuahua, Mexico, 
Manufacturer: BioSense Webster, Inc., Irwindale, CA. 
REASON
Biosense Webster reported that one of the Printed Circuit Board (PCB) components used in the NAVISTAR (R) RMT Catheters, may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. The icon then returns to the correct position after the RF application is stopped. However, this movement is only observed on the map viewer and there is no actual movement of the catheter tip. Testing indicates that for shifts of less than approximately 25mm, there is no display of an error message or any other indication that the CARTO RMT System/catheter is malfunctioning and therefore, the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to an unintended locations. This would only be applicable for lesions being created during a linear ablation and would not apply to a focal lesion ablation since the icon returns to the true position between RF applications and location is typically verified using the ECG. This condition does not impact any other ancillary visualization equipment. A shift in the ablation catheter icon can be detected by paying close attention to the location of the ablation catheter icon on the map viewer when applying RF energy. Consistent with the CARTO (R) RMT System manual, it is also recommended to check the position of the catheter by observing the electrograms prior to applying RF energy.
VOLUME OF PRODUCT IN COMMERCE
4,739 units
DISTRIBUTION Nationwide

PRODUCT  Zimmer Dynesys top-loading cutter, spacer; REF 07.01284.001. 
CODE
All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, 
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. 
REASON
The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom

PRODUCT  Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603. 
CODE
Lot Numbers: 08BM09885, 08EM06396, 08FM14910, 08HM10480, 08KM07754, 08KM12526, 08HM03206, 08GM03007R, 08EM19444, 08EM19445, 08EM19446, 08EM20186, 08FM00231, 08RM00242, 08FM03526, 08FM04628, 08FM05689, 08FM06247, 08FM14906, 08FM17347, 08FM22085, 08FM22087, 08GM03007, 08GM03489, 08GM06660, 08GM11382, 08GM11425, 08GM12094, 08GM13061, 08GM17805, 08GM18609, 08HM02631, 08HM03926, 08HM10037, 08HM13107, 08HM13118, 08HM16147, 08HM16150, 08HM17621, 08HM18516, 08JM00370, 08JM04970, 08JM04971, 08JM05505, 08JM05506, 08JM08122, 08JM09041, 08JM11262, 08JM14571, 08JM15417, 08JM19246, 08JM19247, 08JM19248, 08JM20328, 08JM21716, 08JM21717, 08JM21718, 08KM03713, 08KM07732, 08KM14807, 08KM20680, 08KM23716, 08LM01328, 08LM02300, 08LM11759, 08LM12842, and 08LM13924
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, 
REASON
Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.
VOLUME OF PRODUCT IN COMMERCE
925 units
DISTRIBUTION Nationwide, Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France

PRODUCT 
1) AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device. 

2) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. 

3) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. 
CODE
1) Lot Number 50278012;
2) Lot Number 502780141;
3) Lot Number 50278014
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA,
REASON
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland

PRODUCT  Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. 
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Philips Lifeline, Inc., Farmingham, MA, 
REASON
Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.
VOLUME OF PRODUCT IN COMMERCE
750,000 units
DISTRIBUTION Nationwide, Canada

PRODUCT 
Kuschall K Junior Manual wheelchair. Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193. 
CODE Model numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, 
Manufacturer: Kuschall Design AG, Allschwil, Switzerland. 
REASON
The handle has been breaking at a calculated weight of 65kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).
VOLUME OF PRODUCT IN COMMERCE
14 wheelchairs
DISTRIBUTION CA, CO, MN, NJ, OR, PA, TX, VA, Canada

PRODUCT  HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support. 
CODE
Lot numbers are visible on the clips: 458560206, 581080207, 581080507, 34331720107, 34404690108, 34532990109, 343317201407, 34331720207, 34331720507, 34404690208, 34404690308, 34404690408, 34432810108, 34450070108, 34477720108, 34570570109, 34577730109, and 34331720307
RECALLING FIRM/MANUFACTURER
Thoratec, Corp., Pleasanton, CA
REASON
Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled correctly, this may interfere with the ability to connect the system to a power source, and subsequently to interrupt pump function.
VOLUME OF PRODUCT IN COMMERCE
8,194 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint. 
CODE Lot number: K10747, K10677, and K10510
RECALLING FIRM/MANUFACTURER
Recall Firm: Tornier, Inc., Edina, MN, Manufacturer: Kinamed Inc., Camarillo, CA. 
REASON
Mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION CA, FL, MD, MI, NJ, OH, PA, and France

PRODUCT  GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. 
CODE Software versions 1.0.x, 2.0.x, 2.1.x, and 3.0.x.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL,
REASON
There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
1,188 units
DISTRIBUTION Nationwide, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom

PRODUCT  Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. 
CODE
Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926
RECALLING FIRM/MANUFACTURER
Nonin Medical, Inc., Plymouth, MN,
REASON
A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION LA, MN, NC, NY and Canada, Germany, Italy, Netherlands, and United Kingdom

PRODUCT 
1) Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001. 

2) Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R. 

3) Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101. 

4) Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 727142124, and MDS89755R.

5) Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R. 

6) Shower Seat, Non-rotating, Catalog number 727152000. 

7) Shower Seat, Rotating, Catalog number 727152100. 
CODE Devices are not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 is being recalled.
RECALLING FIRM/MANUFACTURER
Nutech Manufacturing Corp., Pocomoke City, MD, 
REASON
Safety chair used in shower/bath may not meet specifications for weight load.
VOLUME OF PRODUCT IN COMMERCE
3,627 units
DISTRIBUTION Nationwide and Canada

PRODUCT  Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories. 
CODE No serial or lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, 
Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. REASON
Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION Nationwide

PRODUCT TempSpan Dual-Cure Temporary Crown and Bridge Material, Part number N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. 
CODE Lot number: 191691
RECALLING FIRM/MANUFACTURER
Jeneric/Pentron, Wallingford, CT
REASON
Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION Nationwide

PRODUCT 
1) Axiom Artis MP, Model number 5904466 angiographic x-ray systems. 

2) Axiom Artis dMP, Model number 7555365 angiographic x-ray systems. 

3) Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems. 
CODE
1) Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363;

2) Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204;

3) Serial numbers: 157136, 157139, 157146, 157156, 157164, 157165, 157168, 157169, 157184, 157213, and 157215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions, Inc., Erlangen, Germany. REASON
C-arm may tilt.
VOLUME OF PRODUCT IN COMMERCE
113 units
DISTRIBUTION Nationwide

PRODUCT  Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002. 
CODE
Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
RECALLING FIRM/MANUFACTURER
Sybronendo, Orange, CA, 
REASON
The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More specifically, there exists a possibility that if the lock nut were to fail, the cartridge could fall out onto patients or users and could cause a burn.
VOLUME OF PRODUCT IN COMMERCE
5,046 units
DISTRIBUTION Nationwide, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela

PRODUCT  Zodiac Polyaxial Spinal Fixation System. Part Number: 62665-50. 
CODE Lot Number: 617945
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA
REASON
Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION AZ, CA, FL, TX

PRODUCT  ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520. The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site. 
CODE Lot number: 5271901
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA,
REASON
The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION AZ, CA, OR, TX, Tokyo, Japan

PRODUCT  Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile; REF AVACT.
CODE
Lot numbers: 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, 
Manufacturer: Zimmer Dental, Inc., Carlsbad, CA. 
REASON
The devices may not meet specifications, which may result in fracturing during tightening of the component.
VOLUME OF PRODUCT IN COMMERCE
738 units
DISTRIBUTION OH, Canada, France

PRODUCT  Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile, REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions. 
CODE
All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN,
Manufacturer: Biomet sports Medicine, Inc., Ontario, CA. 
REASON
These anchors may be difficult to remove, or may not detach from the inserter shaft.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION Nationwide and Belgium

PRODUCT 
1) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 11mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). 

2) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 13mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). 
CODE
1) Lot numbers: 098705608 and 098705609;
2) Lot number: 098705612
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, 
REASON
Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, Greece

WEEK ENDING DECEMBER 12

PRODUCT Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. 
CODE Version 4.6, 6.1, 7.0 or 7.1 labeling
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX,
REASON
Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists that prevents the lead from delivering therapy to the vagus nerve.
VOLUME OF PRODUCT IN COMMERCE
9,500 programming devices
DISTRIBUTION Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela

PRODUCT
1) Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691. 

2)  Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Slice Mobile; GEMINI TF CT/PET System 64 Slice Mobile; and GEMINI TF CT/PET System 64 Slice. Model Numbers: 16 slice: 4535 679 83931; 64 slice Mobile: 4535 674 47551; and 64 slice: 4535 679 94741. CODE
1) Serial Numbers: 4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175;

2) Serial Numbers: Gemini TF 16 Slice: 7005, 7052, 7087, 7112, 7121, 7138, 7115, 7135, 7006, 7008, 7015, 7021, 7020, 7026, 7035, 7039, 7041, 7049, 7053, 7058, 7060, 7069, 7075, 7080, 7083, 7084, 7098, 7117, 7118, 7142; Gemini TF 16 Slice Mobile: 7059, 7104; Gemini TF 64 Slice Mobile: 7092; Gemini TF 64 Slice: 7012, 7013, 7032, 7071, 7082, 7091, 7126, 7132, 7088, 7103, 7136, 7027, 7109, 7105, 7028, 7167, 7078, and 7110
RECALLING FIRM/MANUFACTURER
The Philips Medical Systems (Cleveland), Cleveland, OH, 
REASON
A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION Nationwide, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain and Sweden

PRODUCT PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. 
CODE Software version 7.2.2
RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, 
REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom

PRODUCT
1) Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component. Catalog number 6260-5-326. 

2) Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component. Catalog number 6260-9-132. CODE
1) Lot code 29018201;
2) Lot Code 28759003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, 
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. 
REASON
Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
VOLUME OF PRODUCT IN COMMERCE
6260-5-326 – 7 units; 6260-9-132 – 10 units
DISTRIBUTION Nationwide

PRODUCT Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A. 
CODE Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., Chester, VA, 
REASON
Surgical gloves in hospital convenience kits may be degraded and tear during use.
VOLUME OF PRODUCT IN COMMERCE
378 units
DISTRIBUTION TX, CO

PRODUCT The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System". Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish). 
CODE
Serial Numbers: 60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656
RECALLING FIRM/MANUFACTURER
Natus Medical Incorporated, Seattle, WA, 
REASON
The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.
VOLUME OF PRODUCT IN COMMERCE
2127 units
DISTRIBUTION Nationwide, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK

PRODUCT
1) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal implant component. Catalog Number 48036022. 

2) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal implant component. Catalog number 4803625.

3) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal implant component. Catalog number 48036028. 

4) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal implant component. Catalog number 48036031. 

5) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal implant component. Catalog number 48036034. 

6) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal implant component. Catalog number 48036027.

7) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component. Catalog number 48036040. 

8) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM, spinal implant component. Catalog number 48036043. 

9) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM, spinal implant component. Catalog number 48036046. 

10) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM, spinal implant component. Catalog number 48036049. 

11) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM, spinal implant component. Catalog number 48036052. 

12) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM, spinal implant component. Catalog number 48036055. 

13) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM, spinal implant component. Catalog number 48036058. 

14) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM, spinal implant component. Catalog number 48036061. 

15) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM, spinal implant component. Catalog number 48036064. 

16) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component. Catalog number 48036067. 

17) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal implant component . Catalog number 48036522. 

18) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal implant component. Catalog number 48036525. 

19) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal implant component. Catalog number 48036528. 

20) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal implant component. Catalog number 48036531. 

21) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal implant component. Catalog number 48036534. 

22) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component. Catalog number 48036537. 

23) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM, spinal implant component. Catalog number 38036540. 

24) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM, spinal implant component. Catalog number 48036543. 

25) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM, spinal implant component. Catalog number 48036546. 

26) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spinal implant component. Catalog number 48036549. 

27) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spinal implant component. Catalog number 48036552. 

28) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM, spinal implant component. Catalog number 48036555. 

29) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM, spinal implant component. Catalog number 48036558. 

30) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM, spinal implant component. Catalog number 48036561. 

31) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component. Catalog number 48036564. 

 32) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM, spinal implant component. Catalog number 48036567. 
CODE All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, 
Manufacturer: Stryker Spine, Cestas, Aquitane, France. 
REASON
Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
VOLUME OF PRODUCT IN COMMERCE
9550 screws
DISTRIBUTION Nationwide

PRODUCT Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064. 
CODE Lot number: Jan-12-05
RECALLING FIRM/MANUFACTURER
Cargille-Sacher Laboratories, Inc., Cedar Grove, NJ, 
REASON
The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.
VOLUME OF PRODUCT IN COMMERCE
5 kits
DISTRIBUTION OH, DC, PA, WI, VA

PRODUCT ezManager Max Diabetes Management System version 2.0.9. 
CODE Version 2.0.9
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA,
REASON
Printed hard copy of results is not the same as the system screens-carbohydrate to insulin ratio incorrect.
VOLUME OF PRODUCT IN COMMERCE
20,648 units
DISTRIBUTION Nationwide, Canada, Cayman Islands, and Denmark

WEEK ENDING DECEMBER 5

PRODUCT 
1) Medtronic Concerto, C154DWK, Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies.

2) This device is not approved in the United States. Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies.

3) Medtronic Virtuoso DR, D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

4) Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.

5) This device is not approved in the United States. Medtronic Virtuoso DR, D164AWG.

6) This device is not approved in the United States. Medtronic Virtuoso VR, D164VWC.
CODE
1) Serial numbers: PVR400002H, PVR400004H, PVR400005H, PVR400009H, PVR400018H, PVR400026H, PVR400032H, PVR400054H, PVR400055H, PVR400058H, PVR400061H, PVR400063H, PVR400064H, PVR400073H, PVR400080H, PVR400083H, PVR400086H, PVR400091H, PVR400097H, PVR400105H, PVR400114H, PVR400119H, PVR400121H, PVR400122H, PVR400124H, PVR400129H, PVR400133H, PVR400137H, PVR400138H, PVR400151H, PVR400156H, PVR400159H, PVR400160H, PVR400163H, PVR400164H, PVR400166H, PVR400171H, PVR400176H, PVR400180H, PVR400183H, PVR400184H, PVR400199H, PVR400206H, PVR400209H, PVR400216H, PVR400218H, PVR400220H, PVR400222H, PVR400224H, PVR400227H, PVR400228H, PVR400230H, PVR400231H, PVR400238H, PVR400239H, PVR400244H, PVR400245H, PVR400246H, PVR400249H, PVR400250H, PVR400251H, PVR400254H, PVR400258H, PVR400259H, PVR400281H, PVR400284H, PVR400287H, PVR400292H, PVR400294H, PVR400295H, PVR400296H, PVR400297H, PVR400300H, PVR400301H, PVR400303H, PVR400306H, PVR400308H, PVR400315H, PVR400334H, PVR400340H, PVR400349H, PVR400351H, PVR400355H, PVR400365H, PVR400368H, PVR400370H, PVR400372H, PVR400373H, PVR400375H, PVR400380H, PVR400387H, PVR400399H, PVR400404H, PVR400411H, PVR400413H, PVR400417H, PVR400419H, PVR400420H, PVR400421H, PVR400422H, PVR400423H, PVR400427H, PVR400428H, PVR400437H, PVR400442H, PVR400443H, PVR400445H, PVR400447H, PVR400449H, PVR400452H, PVR400453H, PVR400458H, PVR400461H, PVR400466H, PVR400467H, PVR400475H, PVR400477H, PVR400480H, PVR400481H, PVR400483H, PVR400487H, PVR400491H, PVR400492H, PVR400496H, PVR400499H, PVR400500H, PVR400503H, PVR400507H, PVR400508H, PVR400511H, PVR400512H, PVR400524H, PVR400526H, PVR400529H, PVR400531H, PVR400532H, PVR400535H, PVR400543H, PVR400550H, PVR400554H, PVR400556H, PVR400563H, PVR400564H, PVR400565H, PVR400566H, PVR400570H, PVR400571H, PVR400574H, PVR400578H, PVR400580H, PVR400584H, PVR400588H, PVR400593H, PVR400598H, PVR400601H, PVR400608H, PVR400610H, PVR400611H, PVR400621H, PVR400622H, PVR400628H, PVR400629H, PVR400633H, PVR400634H, PVR400636H, PVR400638H, PVR400642H, PVR400643H, PVR400651H, PVR400658H, PVR400666H, PVR400674H, PVR400675H, PVR400681H, PVR400682H, PVR400687H, PVR400692H, PVR400700H, PVR400704H, PVR400707H, PVR400725H, PVR400726H, PVR400729H, PVR400731H, PVR400733H, PVR400736H, PVR400738H, PVR400745H, PVR400746H, PVR400750H, PVR400752H, PVR400758H, PVR400759H, PVR400778H, PVR400782H, PVR400784H, PVR400788H, PVR400789H, PVR400797H, PVR400799H, PVR400803H, PVR400806H, PVR400807H, PVR400810H, PVR400811H, PVR400812H, PVR400813H, PVR400817H, PVR400819H, PVR400820H, PVR400823H, PVR400826H, PVR400832H, PVR400833H, PVR400838H, PVR400850H, PVR400856H, PVR400859H, PVR400867H, PVR400875H, PVR400882H, PVR400887H, PVR400896H, PVR400902H, PVR400907H, PVR400909H, PVR400911H, PVR400912H, PVR400914H, PVR400918H, PVR400922H, PVR400929H, PVR400930H, PVR400936H, PVR400939H, PVR400941H, PVR400944H, PVR400945H, PVR400946H, PVR400947H, PVR400950H, PVR400952H, PVR400959H, PVR400960H, PVR400961H, PVR400965H, PVR400966H, PVR400969H, PVR400970H, PVR400975H, PVR400978H, PVR400979H, PVR400983H, PVR400984H, PVR400986H, PVR400992H, PVR400996H, PVR401001H, PVR401002H, PVR401003H, PVR401004H, PVR401005H, PVR401007H, PVR401008H, PVR401009H, PVR401029H, PVR401036H, PVR401037H, PVR401038H, PVR401041H, PVR401042H, PVR401047H, PVR401049H, PVR401050H, PVR401058H, PVR401062H, PVR401071H, PVR401076H, PVR401083H, PVR401092H, PVR401105H, PVR401107H, PVR401109H, PVR401116H, PVR401121H, PVR401125H, PVR401127H, PVR401132H, PVR401133H, PVR401135H, PVR401138H, PVR401142H, PVR401146H, PVR401150H, PVR401153H, PVR401154H, PVR401156H, PVR401161H, PVR401165H, PVR401186H, PVR401191H, PVR401192H, PVR401193H, PVR401195H, PVR401206H, PVR401215H, PVR401225H, PVR401235H, PVR401261H, PVR401264H, PVR401270H, PVR401272H, PVR401279H, PVR401282H, PVR401290H, PVR401294H, PVR401305H, PVR401319H, PVR401324H, PVR401326H, PVR401332H, PVR401334H, PVR401346H, PVR401349H, PVR401360H, PVR401370H, PVR401372H, PVR401379H, PVR401383H, PVR401387H, PVR401388H, PVR401390H, PVR401392H, PVR401396H, PVR401407H, PVR401408H, PVR401414H, PVR401417H, PVR401418H, PVR401435H, PVR401436H, PVR401443H, PVR401451H, PVR401453H, PVR401457H, PVR401463H, PVR401464H, PVR401471H, PVR401473H, PVR401475H, PVR401479H, PVR401480H, PVR401489H, PVR401491H, PVR401496H, PVR401501H, PVR401503H, PVR401514H, PVR401520H, PVR401524H, PVR401525H, PVR401527H, PVR401529H, PVR401531H, PVR401544H, PVR401569H, PVR401571H, PVR401578H, PVR401586H, PVR401592H, PVR401597H, PVR401599H, PVR401608H, PVR401611H, PVR401614H, PVR401615H, PVR401616H, PVR401625H, PVR401634H, PVR401638H, PVR401643H, PVR401650H, PVR401651H, PVR401652H, PVR401654H, PVR401655H, PVR401656H, PVR401659H, PVR401666H, PVR401667H, PVR401668H, PVR401670H, PVR401672H, PVR401675H, PVR401678H, PVR401679H, PVR401681H, PVR401682H, PVR401685H, PVR401686H, PVR401687H, PVR401690H, PVR401691H, PVR401692H, PVR401693H, PVR401694H, PVR401698H, PVR401701H, PVR401703H, PVR401705H, PVR401706H, PVR401710H, PVR401711H, PVR401713H, PVR401715H, PVR401718H, PVR401721H, PVR401724H, PVR401726H, PVR401728H, PVR401733H, PVR401742H, PVR401744H, PVR401745H, PVR401750H, PVR401752H, PVR401753H, PVR401755H, PVR401756H, PVR401757H, PVR401760H, PVR401761H, PVR401763H, PVR401765H, PVR401768H, PVR401777H, PVR401779H, PVR401780H, PVR401782H, PVR401784H, PVR401788H, PVR401793H, PVR401799H, PVR401800H, PVR401801H, PVR401802H, PVR401803H, PVR401809H, PVR401810H, PVR401813H, PVR401814H, PVR401815H, PVR401821H, PVR401823H, PVR401826H, PVR401827H, PVR401829H, PVR401831H, PVR401832H, PVR401835H, PVR401836H, PVR401838H, PVR401846H, PVR401848H, PVR401849H, PVR401850H, PVR401851H, PVR401852H, PVR401853H, PVR401854H, PVR401855H, PVR401857H, PVR401858H, PVR401860H, PVR401861H, PVR401864H, PVR401865H, PVR401867H, PVR401869H, PVR401871H, PVR401872H, PVR401874H, PVR401876H, PVR401878H, PVR401879H, PVR401880H, PVR401881H, PVR401883H, PVR401885H, PVR401887H, PVR401891H, PVR401893H, PVR401895H, PVR401896H, PVR401898H, PVR401906H, PVR401908H, PVR401909H, PVR401910H, PVR401913H, PVR401914H, PVR401916H, PVR401921H, PVR401922H, PVR401924H, PVR401925H, PVR401928H, PVR401929H, PVR401932H, PVR401933H, PVR401934H, PVR401935H, PVR401936H, PVR401948H, PVR401949H, PVR401950H, PVR401951H, PVR401952H, PVR401954H, PVR401956H, PVR401962H, PVR401964H, PVR401972H, PVR401981H, PVR401983H, PVR401984H, PVR401992H, PVR401994H, PVR401997H, PVR402002H, PVR402006H, PVR402007H, PVR402008H, PVR402011H, PVR402016H, PVR402019H, PVR402021H, PVR402024H, PVR402029H, PVR402030H, PVR402031H, PVR402037H, PVR402038H, PVR402041H, PVR402044H, PVR402048H, PVR402050H, PVR402052H, PVR402057H, PVR402059H, PVR402062H, PVR402066H, PVR402068H, PVR402075H, PVR402083H, PVR402087H, PVR402089H, PVR402090H, PVR402093H, PVR402094H, PVR402095H, PVR402101H, PVR402103H, PVR402105H, PVR402106H, PVR402107H, PVR402110H, PVR402112H, PVR402115H, PVR402117H, PVR402118H, PVR402119H, PVR402120H, PVR402121H, PVR402122H, PVR402125H, PVR402126H, PVR402130H, PVR402132H, PVR402137H, PVR402138H, PVR402140H, PVR402141H, PVR402142H, PVR402143H, PVR402144H, PVR402146H, PVR402149H, PVR402150H, PVR402153H, PVR402155H, PVR402156H, PVR402159H, PVR402160H, PVR402163H, PVR402164H, PVR402166H, PVR402169H, PVR402172H, PVR402174H, PVR402176H, PVR402178H, PVR402179H, PVR402180H, PVR402185H, PVR402186H, PVR402187H, PVR402189H, PVR402191H, PVR402192H, PVR402195H, PVR402197H, PVR402199H, PVR402201H, PVR402208H, PVR402211H, PVR402212H, PVR402213H, PVR402214H, PVR402218H, PVR402220H, PVR402222H, PVR402223H, PVR402226H, PVR402228H, PVR402230H, PVR402231H, PVR402232H, PVR402234H, PVR402236H, PVR402238H, PVR402239H, PVR402241H, PVR402242H, PVR402245H, PVR402246H, PVR402247H, PVR402248H, PVR402249H, PVR402250H, PVR402252H, PVR402253H, PVR402256H, PVR402257H, PVR402259H, PVR402263H, PVR402268H, PVR402271H, PVR402272H, PVR402275H, PVR402279H, PVR402282H, PVR402283H, PVR402285H, PVR402290H, PVR402291H, PVR402292H, PVR402293H, PVR402295H, PVR402304H, PVR402306H, PVR402308H, PVR402315H, PVR402317H, PVR402319H, PVR402320H, PVR402322H, PVR402324H, PVR402325H, PVR402330H, PVR402337H, PVR402339H, PVR402340H, PVR402341H, PVR402343H, PVR402345H, PVR402346H, PVR402348H, PVR402350H, PVR402351H, PVR402356H, PVR402358H, PVR402361H, PVR402362H, PVR402363H, PVR402364H, PVR402365H, PVR402366H, PVR402368H, PVR402369H, PVR402370H, PVR402371H, PVR402372H, PVR402373H, PVR402374H, PVR402375H, PVR402376H, PVR402378H, PVR402380H, PVR402381H, PVR402383H, PVR402384H, PVR402385H, PVR402387H, PVR402391H, PVR402392H, PVR402393H, PVR402394H, PVR402396H, PVR402397H, PVR402398H, PVR402399H, PVR402400H, PVR402403H, PVR402404H, PVR402405H, PVR402407H, PVR402411H, PVR402416H, PVR402418H, PVR402420H, PVR402421H, PVR402422H, PVR402424H, PVR402428H, PVR402433H, PVR402434H, PVR402435H, PVR402439H, PVR402441H, PVR402442H, PVR402443H, PVR402447H, PVR402454H, PVR402456H, PVR402459H, PVR402461H, PVR402465H, PVR402468H, PVR402469H, PVR402470H, PVR402476H, PVR402478H, PVR402480H, PVR402481H, PVR402482H, PVR402483H, PVR402484H, PVR402487H, PVR402490H, PVR402491H, PVR402492H, PVR402493H, PVR402494H, PVR402495H, PVR402497H, PVR402498H, PVR402499H, PVR402501H, PVR402502H, PVR402504H, PVR402505H, PVR402506H, PVR402507H, PVR402508H, PVR402511H, PVR402514H, PVR402520H, PVR402526H, PVR402527H, PVR402530H, PVR402531H, PVR402532H, PVR402533H, PVR402534H, PVR402537H, PVR402539H, PVR402540H, PVR402541H, PVR402543H, PVR402546H, PVR402547H, PVR402550H, PVR402552H, PVR402553H, PVR402554H, PVR402555H, PVR402559H, PVR402560H, PVR402561H, PVR402563H, PVR402565H, PVR402566H, PVR402568H, PVR402569H, PVR402570H, PVR402571H, PVR402572H, PVR402574H, PVR402575H, PVR402578H, PVR402580H, PVR402583H, PVR402584H, PVR402588H, PVR402589H, PVR402592H, PVR402594H, PVR402596H, PVR402598H, PVR402599H, PVR402601H, PVR402602H, PVR402605H, PVR402606H, PVR402607H, PVR402608H, PVR402609H, PVR402611H, PVR402612H, PVR402613H, PVR402614H, PVR402616H, PVR402617H, PVR402620H, PVR402623H, PVR402624H, PVR402625H, PVR402630H, PVR402632H, PVR402633H, PVR402634H, PVR402635H, PVR402638H, PVR402640H, PVR402641H, PVR402642H, PVR402643H, PVR402644H, PVR402647H, PVR402652H, PVR402653H, PVR402655H, PVR402656H, PVR402657H, PVR402659H, PVR402660H, PVR402662H, PVR402663H, PVR402664H, PVR402666H, PVR402670H, PVR402672H, PVR402673H, PVR402674H, PVR402675H, PVR402678H, PVR402680H, PVR402683H, PVR402684H, PVR402689H, PVR402690H, PVR402691H, PVR402693H, PVR402695H, PVR402697H, PVR402699H, PVR402700H, PVR402704H, PVR402705H, PVR402706H, PVR402709H, PVR402710H, PVR402712H, PVR402714H, PVR402716H, PVR402717H, PVR402718H, PVR402721H, PVR402722H, PVR402723H, PVR402724H, PVR402726H, PVR402728H, PVR402730H, PVR402731H, PVR402733H, PVR402735H, PVR402736H, PVR402737H, PVR402739H, PVR402740H, PVR402742H, PVR402743H, PVR402744H, PVR402747H, PVR402749H, PVR402751H, PVR402753H, PVR402754H, PVR402755H, PVR402759H, PVR402760H, PVR402761H, PVR402763H, PVR402764H, PVR402765H, PVR402769H, PVR402770H, PVR402771H, PVR402774H, PVR402775H, PVR402776H, PVR402779H, PVR402781H, PVR402782H, PVR402783H, PVR402784H, PVR402785H, PVR402786H, PVR402787H, PVR402788H, PVR402789H, PVR402795H, PVR402796H, PVR402797H, PVR402798H, PVR402799H, PVR402803H, PVR402804H, PVR402806H, PVR402812H, PVR402813H, PVR402815H, PVR402816H, PVR402820H, PVR402821H, PVR402822H, PVR402824H, PVR402825H, PVR402826H, PVR402827H, PVR402828H, PVR402830H, PVR402833H, PVR402834H, PVR402836H, PVR402841H, PVR402843H, PVR402844H, PVR402845H, PVR402847H, PVR402849H, PVR402851H, PVR402852H, PVR402853H, PVR402857H, PVR402859H, PVR402860H, PVR402862H, PVR402864H, PVR402866H, PVR402867H, PVR402868H, PVR402870H, PVR402871H, PVR402875H, PVR402876H, PVR402880H, PVR402882H, PVR402883H, PVR402884H, PVR402886H, PVR402887H, PVR402889H, PVR402890H, PVR402891H, PVR402892H, PVR402895H, PVR402896H, PVR402899H, PVR402900H, PVR402901H, PVR402902H, PVR402904H, PVR402905H, PVR402907H, PVR402909H, PVR402910H, PVR402917H, PVR402918H, PVR402922H, PVR402923H, PVR402924H, PVR402925H, PVR402926H, PVR402927H, PVR402928H, PVR402930H, PVR402932H, PVR402933H, PVR402934H, PVR402937H, PVR402938H, PVR402939H, PVR402942H, PVR402943H, PVR402944H, PVR402946H, PVR402951H, PVR402952H, PVR402954H, PVR402959H, PVR402960H, PVR402962H, PVR402964H, PVR402965H, PVR402970H, PVR402971H, PVR402972H, PVR402973H, PVR402974H, PVR402975H, PVR402979H, PVR402980H, PVR402983H, PVR402984H, PVR402985H, PVR402986H, PVR402989H, PVR402990H, PVR402991H, PVR402995H, PVR402996H, PVR402997H, PVR402999H, PVR403002H, PVR403004H, PVR403005H, PVR403006H, PVR403007H, PVR403009H, PVR403010H, PVR403014H, PVR403018H, PVR403019H, PVR403023H, PVR403025H, PVR403027H, PVR403029H, PVR403030H, PVR403032H, PVR403033H, PVR403036H, PVR403037H, PVR403041H, PVR403044H, PVR403047H, PVR403049H, PVR403050H, PVR403051H, PVR403056H, PVR403060H, PVR403061H, PVR403062H, PVR403067H, PVR403069H, PVR403072H, PVR403074H, PVR403077H, PVR403081H, PVR403082H, PVR403083H, PVR403085H, PVR403089H, PVR403093H, PVR403096H, PVR403097H, PVR403098H, PVR403099H, PVR403101H, PVR403104H, PVR403109H, PVR403111H, PVR403113H, PVR403115H, PVR403116H, PVR403119H, PVR403120H, PVR403122H, PVR403125H, PVR403126H, PVR403129H, PVR403131H, PVR403133H, PVR403134H, PVR403136H, PVR403138H, PVR403139H, PVR403140H, PVR403141H, PVR403142H, PVR403143H, PVR403144H, PVR403146H, PVR403147H, PVR403148H, PVR403149H, PVR403151H, PVR403152H, PVR403154H, PVR403155H, PVR403158H, PVR403161H, PVR403164H, PVR403166H, PVR403167H, PVR403169H, PVR403170H, PVR403172H, PVR403175H, PVR403182H, PVR403185H, PVR403192H, PVR403199H, PVR403201H, PVR403216H, PVR403220H, PVR403233H, PVR403238H, PVR403241H, PVR403242H, PVR403243H, PVR403266H, PVR403267H, PVR403270H, PVR403272H, PVR403275H, PVR403277H, PVR403278H, PVR403283H, PVR403288H, PVR403291H, PVR403297H, PVR403302H, PVR403305H, PVR403307H, PVR403311H, PVR403315H, PVR403317H, PVR403320H, PVR403324H, PVR403325H, PVR403327H, PVR403329H, PVR403335H, PVR403336H, PVR403337H, PVR403338H, PVR403351H, PVR403352H, PVR403353H, PVR403359H, PVR403360H, PVR403362H, PVR403367H, PVR403369H, PVR403371H, PVR403380H, PVR403381H, PVR403382H, PVR403384H, PVR403390H, PVR403391H, PVR403394H, PVR403395H, PVR403397H, PVR403401H, PVR403402H, PVR403411H, PVR403412H, PVR403414H, PVR403419H, PVR403420H, PVR403421H, PVR403424H, PVR403425H, PVR403426H, PVR403431H, PVR403432H, PVR403433H, PVR403434H, PVR403435H, PVR403437H, PVR403438H, PVR403440H, PVR403444H, PVR403446H, PVR403447H, PVR403448H, PVR403449H, PVR403452H, PVR403453H, PVR403455H, PVR403461H, PVR403462H, PVR403464H, PVR403468H, PVR403470H, PVR403471H, PVR403472H, PVR403473H, PVR403474H, PVR403478H, PVR403479H, PVR403482H, PVR403483H, PVR403489H, PVR403498H, PVR403499H, PVR403500H, PVR403501H, PVR403507H, PVR403509H, PVR403510H, PVR403513H, PVR403514H, PVR403516H, PVR403518H, PVR403521H, PVR403533H, PVR403534H, PVR403538H, PVR403539H, PVR403541H, PVR403543H, PVR403545H, PVR403550H, PVR403552H, PVR403553H, PVR403556H, PVR403557H, PVR403561H, PVR403570H, PVR403586H, PVR403591H, PVR403604H, PVR403606H, PVR403614H, PVR403619H, PVR403623H, PVR403628H, PVR403629H, PVR403631H, PVR403632H, PVR403636H, PVR403639H, PVR403654H, PVR403665H, PVR403678H, PVR403683H, PVR403694H, PVR403704H, PVR403715H, PVR403720H, PVR403725H, PVR403734H, PVR403742H, PVR403755H, PVR403756H, PVR403765H, PVR403766H, PVR403770H, PVR403774H, PVR403776H, PVR403779H, PVR403784H, PVR403786H, PVR403801H, PVR403803H, PVR403813H, PVR403814H, PVR403817H, PVR403820H, PVR403823H, PVR403826H, PVR403835H, PVR403838H, PVR403841H, PVR403842H, PVR403846H, PVR403849H, PVR403851H, PVR403853H, PVR403855H, PVR403857H, PVR403858H, PVR403859H, PVR403865H, PVR403870H, PVR403871H, PVR403876H, PVR403878H, PVR403880H, PVR403883H, PVR403886H, PVR403887H, PVR403889H, PVR403890H, PVR403895H, PVR403900H, PVR403901H, PVR403902H, PVR403903H, PVR403906H, PVR403907H, PVR403909H, PVR403910H, PVR403912H, PVR403915H, PVR403916H, PVR403919H, PVR403923H, PVR403925H, PVR403926H, PVR403928H, PVR403929H, PVR403930H, PVR403932H, PVR403934H, PVR403935H, PVR403954H, PVR403964H, PVR403967H, PVR403968H, PVR403970H, PVR403975H, PVR403976H, PVR403978H, PVR403981H, PVR403995H, PVR403998H, PVR404006H, PVR404008H, PVR404010H, PVR404021H, PVR404026H, PVR404027H, PVR404030H, PVR404035H, PVR404038H, PVR404039H, PVR404042H, PVR404045H, PVR404050H, PVR404051H, PVR404052H, PVR404055H, PVR404060H, PVR404061H, PVR404062H, PVR404063H, PVR404091H, PVR404101H, PVR404107H, PVR404109H, PVR404114H, PVR404116H, PVR404117H, PVR404118H, PVR404134H, PVR404140H, PVR404141H, PVR404143H, PVR404146H, PVR404149H, PVR404150H, PVR404153H, PVR404159H, PVR404160H, PVR404161H, PVR404162H, PVR404163H, PVR404167H, PVR404175H, PVR404176H, PVR404178H, PVR404182H, PVR404186H, PVR404193H, PVR404195H, PVR404198H, PVR404205H, PVR404206H, PVR404208H, PVR404212H, PVR404214H, PVR404223H, PVR404227H, PVR404230H, PVR404237H, PVR404239H, PVR404240H, PVR404241H, PVR404245H, PVR404255H, PVR404259H, PVR404263H, PVR404265H, PVR404266H, PVR404273H, PVR404274H, PVR404275H, PVR404279H, PVR404280H, PVR404286H, PVR404288H, PVR404289H, PVR404291H, PVR404292H, PVR404294H, PVR404296H, PVR404300H, PVR404308H, PVR404317H, PVR404318H, PVR404326H, PVR404328H, PVR404329H, PVR404332H, PVR404337H, PVR404339H, PVR404340H, PVR404341H, PVR404346H, PVR404357H, PVR404358H, PVR404363H, PVR404368H, PVR404369H, PVR404372H, PVR404373H, PVR404374H, PVR404378H, PVR404384H, PVR404389H, PVR404392H, PVR404399H, PVR404404H, PVR404407H, PVR404414H, PVR404415H, PVR404417H, PVR404419H, PVR404420H, PVR404425H, PVR404433H, PVR404436H, PVR404439H, PVR404443H, PVR404457H, PVR404460H, PVR404472H, PVR404476H, PVR404485H, PVR404488H, PVR404492H, PVR404496H, PVR404497H, PVR404499H, PVR404506H, PVR404508H, PVR404513H, PVR404514H, PVR404515H, PVR404521H, PVR404522H, PVR404523H, PVR404524H, PVR404527H, PVR404528H, PVR404532H, PVR404534H, PVR404536H, PVR404548H, PVR404549H, PVR404550H, PVR404551H, PVR404554H, PVR404556H, PVR404557H, PVR404559H, PVR404560H, PVR404561H, PVR404562H, PVR404563H, PVR404564H, PVR404568H, PVR404574H, PVR404577H, PVR404579H, PVR404580H, PVR404581H, PVR404582H, PVR404588H, PVR404605H, PVR404610H, PVR404623H, PVR404630H, PVR404633H, PVR404635H, PVR404645H, PVR404646H, PVR404651H, PVR404652H, PVR404693H, PVR404694H, PVR404699H, PVR404715H, PVR404731H, PVR404741H, PVR404742H, PVR404749H, PVR404765H, PVR404768H, PVR404776H, PVR404782H, PVR404786H, PVR404788H, PVR404791H, PVR404795H, PVR404807H, PVR404809H, PVR404812H, PVR404813H, PVR404825H, PVR404827H, PVR404832H, PVR404834H, PVR404838H, PVR404863H, PVR404866H, PVR404867H, PVR404869H, PVR404871H, PVR404877H, PVR404884H, PVR404885H, PVR404886H, PVR404895H, PVR404897H, PVR404899H, PVR404903H, PVR404910H, PVR404916H, PVR404918H, PVR404922H, PVR404976H, PVR404980H, PVR404984H, PVR404985H, PVR404986H, PVR404987H, PVR404989H, PVR404990H, PVR404998H, PVR404999H, PVR405002H, PVR405003H, PVR405007H, PVR405015H, PVR405027H, PVR405029H, PVR405031H, PVR405032H, PVR405034H, PVR405038H, PVR405041H, PVR405044H, PVR405046H, PVR405050H, PVR405065H, PVR405074H, PVR405079H, PVR405081H, PVR405087H, PVR405091H, PVR405102H, PVR405105H, PVR405109H, PVR405110H, PVR405112H, PVR405113H, PVR405114H, PVR405117H, PVR405125H, PVR405129H, PVR405131H, PVR405136H, PVR405137H, PVR405138H, PVR405139H, PVR405140H, PVR405155H, PVR405157H, PVR405169H, PVR405177H, PVR405184H, PVR405187H, PVR405193H, PVR405195H, PVR405198H, PVR405210H, PVR405215H, PVR405217H, PVR405218H, PVR405220H, PVR405221H, PVR405223H, PVR405224H, PVR405228H, PVR405229H, PVR405230H, PVR405233H, PVR405234H, PVR405236H, PVR405241H, PVR405245H, PVR405246H, PVR405253H, PVR405256H, PVR405259H, PVR405263H, PVR405265H, PVR405266H, PVR405269H, PVR405270H, PVR405282H, PVR405285H, PVR405289H, PVR405298H, PVR405323H, PVR405325H, PVR405328H, PVR405334H, PVR405335H, PVR405336H, PVR405340H, PVR405341H, PVR405343H, PVR405346H, PVR405349H, PVR405350H, PVR405351H, PVR405355H, PVR405368H, PVR405373H, PVR405378H, PVR405381H, PVR405386H, PVR405391H, PVR405394H, PVR405406H, PVR405409H, PVR405423H, PVR405428H, PVR405434H, PVR405435H, PVR405437H, PVR405438H, PVR405443H, PVR405446H, PVR405448H, PVR405450H, PVR405451H, PVR405453H, PVR405458H, PVR405459H, PVR405460H, PVR405480H, PVR405482H, PVR405483H, PVR405493H, PVR405495H, PVR405498H, PVR405503H, PVR405509H, PVR405515H, PVR405516H, PVR405517H, PVR405518H, PVR405521H, PVR405530H, PVR405533H, PVR405548H, PVR405556H, PVR405569H, PVR405571H, PVR405572H, PVR405574H, PVR405578H, PVR405579H, PVR405584H, PVR405586H, PVR405587H, PVR405588H, PVR405589H, PVR405590H, PVR405591H, PVR405592H, PVR405595H, PVR405612H, PVR405613H, PVR405615H, PVR405622H, PVR405625H, PVR405630H, PVR405632H, PVR405649H, PVR405650H, PVR405652H, PVR405656H, PVR405660H, PVR405661H, PVR405662H, PVR405686H, PVR405695H, PVR405697H, PVR405700H, PVR405715H, PVR405720H, PVR405723H, PVR405724H, PVR405733H, PVR405734H, PVR405738H, PVR405739H, PVR405744H, PVR405750H, PVR405756H, PVR405757H, PVR405770H, PVR405779H, PVR405783H, PVR405785H, PVR405795H, PVR405802H, PVR405830H, PVR405833H, PVR405837H, PVR405838H, PVR405840H, PVR405846H, PVR405847H, PVR405853H, PVR405854H, PVR405855H, PVR405857H, PVR405859H, PVR405867H, PVR405871H, PVR405874H, PVR405878H, PVR405881H, PVR405883H, PVR405889H, PVR405890H, PVR405901H, PVR405910H, PVR405911H, PVR405926H, PVR405928H, PVR405932H, PVR405935H, PVR405940H, PVR405944H, PVR405948H, PVR405950H, PVR405951H, PVR405956H, PVR405961H, PVR405977H, PVR405978H, PVR405982H, PVR405983H, PVR405996H, PVR406046H, PVR406055H, PVR406060H, PVR406083H, PVR406084H, PVR406099H, PVR406110H, PVR406117H, PVR406146H, PVR406169H, PVR406172H, PVR406181H, PVR406185H, PVR406198H, PVR406211H, PVR406229H, PVR406235H, PVR406248H, PVR406293H, PVR406295H, PVR406319H, PVR406322H, PVR406323H, PVR406325H, PVR406326H, PVR406327H, PVR406328H, PVR406329H, PVR406330H, PVR406331H, PVR406332H, PVR406333H, PVR406334H, PVR406335H, PVR406337H, PVR406338H, PVR406339H, PVR406341H, PVR406342H, PVR406349H, PVR406350H, PVR406351H, PVR406352H, PVR406357H, PVR406358H, PVR406359H, PVR406360H, PVR406361H, PVR406365H, PVR406366H, PVR406369H, PVR406370H, PVR406373H, PVR406374H, PVR406375H, PVR406376H, PVR406377H, PVR406381H, PVR406382H, PVR406383H, PVR406384H, PVR406385H, PVR406386H, PVR406389H, PVR406391H, PVR406392H, PVR406401H, PVR406403H, PVR406405H, PVR406408H, PVR406414H, PVR406417H, PVR406422H, PVR406424H, PVR406426H, PVR406435H, PVR406492H, PVR406496H, PVR406497H, PVR406498H, PVR406499H, PVR406501H, PVR406504H, PVR406505H, PVR406516H, PVR406518H, PVR406519H, PVR406520H, PVR406523H, PVR406527H, PVR406529H, PVR406533H, PVR406540H, PVR406544H, PVR406553H, PVR406555H, PVR406556H, PVR406595H, PVR406631H, PVR406677H, PVR406709H, PVR406711H, PVR406715H, PVR406723H, PVR406724H, PVR406727H, PVR406732H, PVR406733H, PVR406734H, PVR406735H, PVR406738H, PVR406739H, PVR406743H, PVR406766H, PVR406770H, PVR406781H, PVR406785H, PVR406796H, PVR406798H, PVR406805H, PVR406806H, PVR406809H, PVR406816H, PVR406817H, PVR406818H, PVR406826H, PVR406837H, PVR406844H, PVR406855H, PVR406856H, PVR406860H, PVR406885H, PVR406887H, PVR406889H, PVR406894H, PVR406902H, PVR406923H, PVR406932H, PVR406948H, PVR406975H, PVR406998H, PVR407000H, PVR407007H, PVR407030H, PVR407035H, PVR407038H, PVR407042H, PVR407050H, PVR407068H, PVR407069H, PVR407073H, PVR407076H, PVR407082H, PVR407088H, PVR407090H, PVR407104H, PVR407114H, PVR407154H, PVR407166H, PVR407260H, PVR407373H, PVR407395H, PVR407410H, PVR407411H, PVR407418H, PVR407428H, PVR407566H, PVR407577H, PVR407583H, PVR407587H, PVR407658H, PVR407695H, PVR408596H, PVR410027H, PVR424565H, PVR424718H, PVR438796H, PVR600174S, PVR600176S, PVR600209S, PVR600212S, PVR600213S, PVR600217S, PVR600222S, PVR600223S, PVR600224S, PVR600225S, PVR600226S, PVR600228S, PVR600229S, PVR600230S, PVR600233S, PVR600234S, PVR600248S, PVR600249S, PVR600251S, PVR600252S, PVR600258S, PVR600259S, PVR600261S, PVR600264S, PVR600265S, PVR600266S, PVR600268S, PVR600270S, PVR600271S, PVR600273S, PVR600275S, PVR600276S, PVR600278S, PVR600279S, PVR600282S, PVR600285S, PVR600286S, PVR600287S, PVR600291S, PVR600292S, PVR600293S, PVR600294S, PVR600297S, PVR600298S, PVR600300S, PVR600303S, PVR600309S, PVR600310S;

2) 2) Serial numbers: PVU600353S, PVU600444S, PVU600455S, PVU600466S, PVU600476S, PVU600478S, PVU600494S, PVU600497S, PVU600502S, PVU600505S, PVU600506S, PVU600507S, PVU600508S, PVU600512S, PVU600516S, PVU600518S, PVU600520S, PVU600522S, PVU600526S, PVU600529S, PVU600531S, PVU600534S, PVU600535S, PVU600536S, PVU600539S, PVU600543S, PVU600549S, PVU600558S, PVU600561S, PVU600568S, PVU600571S, PVU600573S, PVU600574S, PVU600582S, PVU600585S, PVU600595S, PVU600597S, PVU600598S, PVU600605S, PVU600607S, PVU600612S, PVU600617S, PVU600618S, PVU600619S, PVU600621S, PVU600622S, PVU600627S, PVU600631S, PVU600638S, PVU600640S, PVU600641S, PVU600646S, PVU600648S, PVU600652S, PVU600660S, PVU600664S, PVU600665S, PVU600675S, PVU600679S, PVU600680S, PVU600681S, PVU600682S, PVU600683S, PVU600685S, PVU600692S, PVU600694S, PVU600695S, PVU600698S, PVU600699S, PVU600703S, PVU600706S, PVU600708S, PVU600709S, PVU600711S, PVU600713S, PVU600718S, PVU600719S, PVU600721S, PVU600722S, PVU600723S, PVU600729S, PVU600767S, PVU600768S, PVU600781S, PVU600800S, PVU600806S, PVU600807S, PVU600808S, PVU600816S, PVU600819S, PVU600823S, PVU600825S, PVU600833S, PVU600834S, PVU600837S, PVU600840S, PVU600892S, PVU600898S, PVU600917S, PVU600949S, PVU600951S, PVU600957S, PVU600961S, PVU601001S, PVU601011S, PVU601012S, PVU601015S, PVU601020S, PVU601034S, PVU601035S, PVU601044S, PVU601052S, PVU601054S, PVU601058S, PVU601085S, PVU601108S, PVU601110S, PVU601115S, PVU601117S, PVU601120S, PVU601124S, PVU601133S, PVU601136S, PVU601140S, PVU601141S, PVU601142S, PVU601146S, PVU601147S, PVU601151S, PVU601153S, PVU601154S, PVU601159S, PVU601160S, PVU601162S, PVU601163S, PVU601164S, PVU601168S, PVU601170S, PVU601171S, PVU601177S, PVU601183S, PVU601190S, PVU601195S, PVU601197S, PVU601210S, PVU601211S, PVU601214S, PVU601219S, PVU601228S, PVU601231S, PVU601233S, PVU601234S, PVU601241S, PVU601243S, PVU601249S, PVU601256S, PVU601257S, PVU601258S, PVU601263S, PVU601269S, PVU601270S, PVU601274S, PVU601276S, PVU601282S, PVU601284S, PVU601285S, PVU601287S, PVU601289S, PVU601293S, PVU601301S, PVU601304S, PVU601314S, PVU601317S, PVU601320S, PVU601322S, PVU601325S, PVU601326S, PVU601329S, PVU601333S, PVU601341S, PVU601342S, PVU601343S, PVU601345S, PVU601350S, PVU601351S, PVU601354S, PVU601366S, PVU601368S, PVU601381S, PVU601398S, PVU601405S, PVU601410S, PVU601413S, PVU601430S, PVU601432S, PVU601433S, PVU601437S, PVU601456S, PVU601495S, PVU601499S, PVU601505S, PVU601519S, PVU601520S, PVU601521S, PVU601523S, PVU601524S, PVU601528S, PVU601532S, PVU601533S, PVU601548S, PVU601551S, PVU601555S, PVU601573S, PVU601577S, PVU601578S, PVU601581S, PVU601582S, PVU601585S, PVU601586S, PVU601592S, PVU601593S, PVU601604S, PVU601607S, PVU601611S, PVU601612S, PVU601614S, PVU601620S, PVU601623S, PVU601625S, PVU601635S, PVU601642S, PVU601651S, PVU601677S, PVU601686S, PVU601688S, PVU601694S, PVU601718S, PVU601719S, PVU601721S, PVU601723S, PVU601836S, PVU613075S, PVU613083S, PVU613107S, PVU613111S, PVU613112S, PVU613119S, PVU613123S, PVU613125S, PVU613127S, PVU613128S, PVU613129S, PVU613139S, PVU613141S, PVU613144S, PVU613151S, PVU613152S, PVU613153S, PVU613159S, PVU613170S, PVU613171S, PVU613177S, PVU613178S, PVU613187S, PVU613200S, PVU613206S, PVU613237S;

3) Serial numbers: PUL400006H, PUL400007H, PUL400009H, PUL400010H, PUL400018H, PUL400022H, PUL400023H, PUL400024H, PUL400030H, PUL400031H, PUL400033H, PUL400034H, PUL400035H, PUL400043H, PUL400046H, PUL400048H, PUL400049H, PUL400051H, PUL400055H, PUL400056H, PUL400058H, PUL400059H, PUL400060H, PUL400062H, PUL400064H, PUL400066H, PUL400069H, PUL400070H, PUL400072H, PUL400074H, PUL400078H, PUL400080H, PUL400081H, PUL400082H, PUL400085H, PUL400086H, PUL400087H, PUL400090H, PUL400091H, PUL400093H, PUL400098H, PUL400102H, PUL400104H, PUL400106H, PUL400108H, PUL400110H, PUL400115H, PUL400118H, PUL400119H, PUL400124H, PUL400132H, PUL400134H, PUL400136H, PUL400141H, PUL400159H, PUL400161H, PUL400162H, PUL400163H, PUL400164H, PUL400170H, PUL400185H, PUL400189H, PUL400191H, PUL400196H, PUL400198H, PUL400203H, PUL400209H, PUL400215H, PUL400217H, PUL400218H, PUL400224H, PUL400225H, PUL400226H, PUL400227H, PUL400230H, PUL400232H, PUL400243H, PUL400245H, PUL400249H, PUL400253H, PUL400256H, PUL400260H, PUL400261H, PUL400263H, PUL400266H, PUL400270H, PUL400271H, PUL400273H, PUL400280H, PUL400281H, PUL400283H, PUL400284H, PUL400290H, PUL400301H, PUL400302H, PUL400303H, PUL400306H, PUL400310H, PUL400312H, PUL400317H, PUL400318H, PUL400319H, PUL400335H, PUL400339H, PUL400344H, PUL400347H, PUL400350H, PUL400351H, PUL400352H, PUL400357H, PUL400358H, PUL400360H, PUL400375H, PUL400378H, PUL400381H, PUL400385H, PUL400388H, PUL400401H, PUL400405H, PUL400406H, PUL400411H, PUL400412H, PUL400413H, PUL400415H, PUL400430H, PUL400434H, PUL400440H, PUL400444H, PUL400449H, PUL400451H, PUL400458H, PUL400460H, PUL400464H, PUL400479H, PUL400480H, PUL400481H, PUL400484H, PUL400488H, PUL400494H, PUL400496H, PUL400498H, PUL400499H, PUL400503H, PUL400504H, PUL400511H, PUL400522H, PUL400527H, PUL400529H, PUL400530H, PUL400533H, PUL400543H, PUL400544H, PUL400550H, PUL400555H, PUL400563H, PUL400566H, PUL400567H, PUL400569H, PUL400573H, PUL400576H, PUL400585H, PUL400600H, PUL400601H, PUL400602H, PUL400608H, PUL400610H, PUL400611H, PUL400613H, PUL400624H, PUL400628H, PUL400632H, PUL400635H, PUL400636H, PUL400637H, PUL400648H, PUL400657H, PUL400662H, PUL400665H, PUL400667H, PUL400668H, PUL400674H, PUL400675H, PUL400677H, PUL400684H, PUL400694H, PUL400696H, PUL400701H, PUL400709H, PUL400728H, PUL400729H, PUL400730H, PUL400740H, PUL400748H, PUL400751H, PUL400768H, PUL400775H, PUL400779H, PUL400788H, PUL400789H, PUL400791H, PUL400794H, PUL400804H, PUL400805H, PUL400807H, PUL400825H, PUL400833H, PUL400835H, PUL400841H, PUL400842H, PUL400846H, PUL400856H, PUL400884H, PUL400885H, PUL400891H, PUL400893H, PUL400895H, PUL400896H, PUL400900H, PUL400901H, PUL400907H, PUL400911H, PUL400915H, PUL400917H, PUL400919H, PUL400920H, PUL400928H, PUL400930H, PUL400935H, PUL400939H, PUL400943H, PUL400948H, PUL400953H, PUL400955H, PUL400956H, PUL400957H, PUL400966H, PUL400968H, PUL400972H, PUL400974H, PUL400975H, PUL400978H, PUL400979H, PUL400986H, PUL400998H, PUL400999H, PUL401002H, PUL401009H, PUL401013H, PUL401018H, PUL401021H, PUL401023H, PUL401026H, PUL401034H, PUL401035H, PUL401037H, PUL401043H, PUL401046H, PUL401047H, PUL401048H, PUL401049H, PUL401050H, PUL401053H, PUL401054H, PUL401055H, PUL401056H, PUL401057H, PUL401060H, PUL401066H, PUL401068H, PUL401069H, PUL401072H, PUL401074H, PUL401075H, PUL401076H, PUL401079H, PUL401083H, PUL401085H, PUL401088H, PUL401090H, PUL401095H, PUL401096H, PUL401097H, PUL401099H, PUL401102H, PUL401107H, PUL401114H, PUL401116H, PUL401117H, PUL401118H, PUL401120H, PUL401121H, PUL401123H, PUL401124H, PUL401125H, PUL401127H, PUL401128H, PUL401130H, PUL401131H, PUL401133H, PUL401134H, PUL401135H, PUL401137H, PUL401140H, PUL401146H, PUL401147H, PUL401148H, PUL401149H, PUL401152H, PUL401153H, PUL401154H, PUL401155H, PUL401156H, PUL401157H, PUL401158H, PUL401160H, PUL401162H, PUL401163H, PUL401165H, PUL401166H, PUL401168H, PUL401169H, PUL401170H, PUL401172H, PUL401173H, PUL401174H, PUL401180H, PUL401182H, PUL401183H, PUL401185H, PUL401186H, PUL401189H, PUL401191H, PUL401193H, PUL401195H, PUL401196H, PUL401197H, PUL401202H, PUL401203H, PUL401204H, PUL401206H, PUL401207H, PUL401212H, PUL401216H, PUL401217H, PUL401218H, PUL401219H, PUL401221H, PUL401222H, PUL401223H, PUL401227H, PUL401228H, PUL401229H, PUL401232H, PUL401234H, PUL401235H, PUL401237H, PUL401238H, PUL401239H, PUL401240H, PUL401241H, PUL401243H, PUL401245H, PUL401246H, PUL401250H, PUL401253H, PUL401254H, PUL401256H, PUL401257H, PUL401258H, PUL401260H, PUL401261H, PUL401262H, PUL401263H, PUL401264H, PUL401266H, PUL401267H, PUL401268H, PUL401270H, PUL401272H, PUL401273H, PUL401274H, PUL401275H, PUL401276H, PUL401277H, PUL401278H, PUL401285H, PUL401286H, PUL401288H, PUL401290H, PUL401293H, PUL401294H, PUL401296H, PUL401297H, PUL401298H, PUL401301H, PUL401305H, PUL401307H, PUL401308H, PUL401310H, PUL401311H, PUL401313H, PUL401315H, PUL401319H, PUL401322H, PUL401323H, PUL401326H, PUL401327H, PUL401328H, PUL401329H, PUL401330H, PUL401331H, PUL401336H, PUL401338H, PUL401339H, PUL401341H, PUL401342H, PUL401343H, PUL401344H, PUL401353H, PUL401354H, PUL401355H, PUL401359H, PUL401360H, PUL401361H, PUL401366H, PUL401367H, PUL401368H, PUL401369H, PUL401370H, PUL401371H, PUL401373H, PUL401375H, PUL401376H, PUL401378H, PUL401380H, PUL401381H, PUL401382H, PUL401385H, PUL401388H, PUL401390H, PUL401392H, PUL401396H, PUL401397H, PUL401400H, PUL401401H, PUL401402H, PUL401403H, PUL401404H, PUL401405H, PUL401406H, PUL401409H, PUL401411H, PUL401413H, PUL401414H, PUL401415H, PUL401416H, PUL401418H, PUL401419H, PUL401420H, PUL401421H, PUL401422H, PUL401426H, PUL401427H, PUL401428H, PUL401429H, PUL401430H, PUL401431H, PUL401432H, PUL401435H, PUL401436H, PUL401438H, PUL401439H, PUL401440H, PUL401443H, PUL401444H, PUL401446H, PUL401448H, PUL401452H, PUL401454H, PUL401455H, PUL401456H, PUL401457H, PUL401459H, PUL401460H, PUL401462H, PUL401463H, PUL401464H, PUL401465H, PUL401467H, PUL401469H, PUL401470H, PUL401472H, PUL401476H, PUL401477H, PUL401478H, PUL401479H, PUL401480H, PUL401483H, PUL401484H, PUL401485H, PUL401486H, PUL401487H, PUL401488H, PUL401489H, PUL401491H, PUL401494H, PUL401495H, PUL401497H, PUL401498H, PUL401500H, PUL401501H, PUL401502H, PUL401504H, PUL401505H, PUL401506H, PUL401507H, PUL401509H, PUL401510H, PUL401512H, PUL401513H, PUL401515H, PUL401516H, PUL401517H, PUL401519H, PUL401521H, PUL401522H, PUL401524H, PUL401525H, PUL401527H, PUL401528H, PUL401530H, PUL401532H, PUL401533H, PUL401534H, PUL401537H, PUL401539H, PUL401541H, PUL401542H, PUL401544H, PUL401547H, PUL401548H, PUL401549H, PUL401550H, PUL401551H, PUL401554H, PUL401557H, PUL401560H, PUL401561H, PUL401564H, PUL401565H, PUL401568H, PUL401569H, PUL401572H, PUL401575H, PUL401576H, PUL401577H, PUL401578H, PUL401581H, PUL401583H, PUL401585H, PUL401586H, PUL401589H, PUL401591H, PUL401592H, PUL401594H, PUL401595H, PUL401596H, PUL401597H, PUL401598H, PUL401600H, PUL401601H, PUL401603H, PUL401604H, PUL401605H, PUL401606H, PUL401607H, PUL401609H, PUL401610H, PUL401612H, PUL401613H, PUL401615H, PUL401616H, PUL401620H, PUL401621H, PUL401624H, PUL401628H, PUL401629H, PUL401630H, PUL401631H, PUL401633H, PUL401634H, PUL401636H, PUL401639H, PUL401640H, PUL401647H, PUL401650H, PUL401651H, PUL401652H, PUL401654H, PUL401657H, PUL401658H, PUL401660H, PUL401661H, PUL401663H, PUL401664H, PUL401666H, PUL401667H, PUL401668H, PUL401670H, PUL401671H, PUL401675H, PUL401676H, PUL401679H, PUL401680H, PUL401681H, PUL401682H, PUL401683H, PUL401687H, PUL401688H, PUL401690H, PUL401692H, PUL401694H, PUL401696H, PUL401700H, PUL401705H, PUL401708H, PUL401709H, PUL401712H, PUL401713H, PUL401714H, PUL401716H, PUL401717H, PUL401718H, PUL401724H, PUL401726H, PUL401727H, PUL401728H, PUL401731H, PUL401732H, PUL401734H, PUL401735H, PUL401737H, PUL401738H, PUL401741H, PUL401742H, PUL401743H, PUL401745H, PUL401746H, PUL401749H, PUL401751H, PUL401753H, PUL401754H, PUL401756H, PUL401757H, PUL401758H, PUL401759H, PUL401760H, PUL401761H, PUL401762H, PUL401763H, PUL401767H, PUL401768H, PUL401769H, PUL401771H, PUL401772H, PUL401773H, PUL401775H, PUL401777H, PUL401779H, PUL401780H, PUL401781H, PUL401782H, PUL401783H, PUL401784H, PUL401786H, PUL401787H, PUL401788H, PUL401789H, PUL401790H, PUL401792H, PUL401793H, PUL401795H, PUL401796H, PUL401797H, PUL401798H, PUL401800H, PUL401802H, PUL401804H, PUL401805H, PUL401807H, PUL401809H, PUL401810H, PUL401813H, PUL401821H, PUL401822H, PUL401825H, PUL401826H, PUL401829H, PUL401830H, PUL401832H, PUL401835H, PUL401836H, PUL401839H, PUL401841H, PUL401842H, PUL401843H, PUL401845H, PUL401847H, PUL401848H, PUL401850H, PUL401852H, PUL401853H, PUL401854H, PUL401855H, PUL401856H, PUL401857H, PUL401858H, PUL401859H, PUL401860H, PUL401861H, PUL401862H, PUL401864H, PUL401865H, PUL401866H, PUL401867H, PUL401870H, PUL401871H, PUL401872H, PUL401873H, PUL401875H, PUL401876H, PUL401877H, PUL401880H, PUL401882H, PUL401883H, PUL401884H, PUL401886H, PUL401887H, PUL401888H, PUL401891H, PUL401893H, PUL401896H, PUL401897H, PUL401899H, PUL401903H, PUL401904H, PUL401905H, PUL401908H, PUL401911H, PUL401913H, PUL401916H, PUL401917H, PUL401919H, PUL401921H, PUL401922H, PUL401923H, PUL401924H, PUL401925H, PUL401926H, PUL401927H, PUL401928H, PUL401929H, PUL401930H, PUL401932H, PUL401934H, PUL401935H, PUL401937H, PUL401938H, PUL401939H, PUL401940H, PUL401941H, PUL401945H, PUL401946H, PUL401947H, PUL401949H, PUL401950H, PUL401951H, PUL401953H, PUL401954H, PUL401955H, PUL401956H, PUL401957H, PUL401963H, PUL401966H, PUL401968H, PUL401969H, PUL401970H, PUL401971H, PUL401972H, PUL401973H, PUL401974H, PUL401976H, PUL401978H, PUL401979H, PUL401980H, PUL401981H, PUL401982H, PUL401985H, PUL401986H, PUL401987H, PUL401989H, PUL401991H, PUL401992H, PUL401994H, PUL401995H, PUL401996H, PUL401997H, PUL402000H, PUL402002H, PUL402004H, PUL402006H, PUL402009H, PUL402010H, PUL402011H, PUL402012H, PUL402013H, PUL402014H, PUL402016H, PUL402019H, PUL402020H, PUL402023H, PUL402024H, PUL402027H, PUL402028H, PUL402031H, PUL402032H, PUL402033H, PUL402034H, PUL402036H, PUL402038H, PUL402041H, PUL402043H, PUL402045H, PUL402046H, PUL402049H, PUL402051H, PUL402053H, PUL402054H, PUL402055H, PUL402058H, PUL402059H, PUL402060H, PUL402061H, PUL402062H, PUL402063H, PUL402064H, PUL402066H, PUL402068H, PUL402070H, PUL402073H, PUL402074H, PUL402076H, PUL402077H, PUL402079H, PUL402080H, PUL402082H, PUL402083H, PUL402084H, PUL402086H, PUL402087H, PUL402088H, PUL402089H, PUL402091H, PUL402093H, PUL402094H, PUL402095H, PUL402096H, PUL402097H, PUL402099H, PUL402102H, PUL402103H, PUL402104H, PUL402105H, PUL402107H, PUL402108H, PUL402109H, PUL402114H, PUL402116H, PUL402118H, PUL402119H, PUL402123H, PUL402124H, PUL402125H, PUL402127H, PUL402128H, PUL402129H, PUL402132H, PUL402133H, PUL402134H, PUL402136H, PUL402138H, PUL402140H, PUL402141H, PUL402143H, PUL402144H, PUL402145H, PUL402149H, PUL402150H, PUL402151H, PUL402152H, PUL402155H, PUL402156H, PUL402158H, PUL402159H, PUL402160H, PUL402161H, PUL402162H, PUL402163H, PUL402164H, PUL402165H, PUL402166H, PUL402167H, PUL402168H, PUL402169H, PUL402172H, PUL402173H, PUL402174H, PUL402177H, PUL402178H, PUL402179H, PUL402180H, PUL402183H, PUL402184H, PUL402186H, PUL402187H, PUL402188H, PUL402189H, PUL402190H, PUL402191H, PUL402194H, PUL402197H, PUL402201H, PUL402202H, PUL402203H, PUL402204H, PUL402205H, PUL402207H, PUL402209H, PUL402210H, PUL402211H, PUL402212H, PUL402213H, PUL402215H, PUL402218H, PUL402220H, PUL402222H, PUL402223H, PUL402225H, PUL402226H, PUL402229H, PUL402230H, PUL402231H, PUL402233H, PUL402234H, PUL402235H, PUL402237H, PUL402239H, PUL402241H, PUL402242H, PUL402245H, PUL402247H, PUL402248H, PUL402250H, PUL402251H, PUL402252H, PUL402253H, PUL402257H, PUL402260H, PUL402261H, PUL402262H, PUL402265H, PUL402266H, PUL402267H, PUL402268H, PUL402270H, PUL402271H, PUL402272H, PUL402275H, PUL402276H, PUL402278H, PUL402279H, PUL402280H, PUL402282H, PUL402285H, PUL402288H, PUL402291H, PUL402292H, PUL402294H, PUL402299H, PUL402300H, PUL402301H, PUL402303H, PUL402304H, PUL402306H, PUL402307H, PUL402308H, PUL402309H, PUL402310H, PUL402313H, PUL402314H, PUL402316H, PUL402318H, PUL402319H, PUL402320H, PUL402321H, PUL402323H, PUL402325H, PUL402326H, PUL402327H, PUL402328H, PUL402332H, PUL402335H, PUL402336H, PUL402338H, PUL402340H, PUL402341H, PUL402343H, PUL402345H, PUL402347H, PUL402348H, PUL402349H, PUL402351H, PUL402355H, PUL402357H, PUL402359H, PUL402360H, PUL402361H, PUL402363H, PUL402365H, PUL402373H, PUL402376H, PUL402379H, PUL402383H, PUL402385H, PUL402389H, PUL402391H, PUL402392H, PUL402396H, PUL402397H, PUL402400H, PUL402401H, PUL402402H, PUL402405H, PUL402407H, PUL402411H, PUL402412H, PUL402413H, PUL402414H, PUL402415H, PUL402417H, PUL402419H, PUL402425H, PUL402427H, PUL402428H, PUL402431H, PUL402432H, PUL402433H, PUL402434H, PUL402437H, PUL402438H, PUL402439H, PUL402441H, PUL402443H, PUL402444H, PUL402445H, PUL402448H, PUL402450H, PUL402451H, PUL402452H, PUL402454H, PUL402455H, PUL402457H, PUL402458H, PUL402460H, PUL402461H, PUL402462H, PUL402464H, PUL402467H, PUL402471H, PUL402473H, PUL402475H, PUL402480H, PUL402482H, PUL402483H, PUL402487H, PUL402488H, PUL402490H, PUL402492H, PUL402493H, PUL402495H, PUL402497H, PUL402498H, PUL402500H, PUL402502H, PUL402507H, PUL402509H, PUL402510H, PUL402513H, PUL402516H, PUL402517H, PUL402519H, PUL402520H, PUL402524H, PUL402525H, PUL402526H, PUL402529H, PUL402530H, PUL402531H, PUL402533H, PUL402535H, PUL402538H, PUL402540H, PUL402541H, PUL402544H, PUL402554H, PUL402555H, PUL402556H, PUL402557H, PUL402558H, PUL402561H, PUL402562H, PUL402565H, PUL402566H, PUL402567H, PUL402568H, PUL402571H, PUL402572H, PUL402573H, PUL402578H, PUL402579H, PUL402581H, PUL402582H, PUL402589H, PUL402592H, PUL402593H, PUL402595H, PUL402597H, PUL402599H, PUL402601H, PUL402604H, PUL402606H, PUL402608H, PUL402611H, PUL402613H, PUL402614H, PUL402615H, PUL402621H, PUL402622H, PUL402624H, PUL402630H, PUL402635H, PUL402636H, PUL402637H, PUL402638H, PUL402649H, PUL402650H, PUL402654H, PUL402655H, PUL402657H, PUL402659H, PUL402661H, PUL402662H, PUL402663H, PUL402665H, PUL402667H, PUL402671H, PUL402673H, PUL402674H, PUL402675H, PUL402676H, PUL402680H, PUL402681H, PUL402683H, PUL402684H, PUL402685H, PUL402689H, PUL402690H, PUL402692H, PUL402693H, PUL402694H, PUL402697H, PUL402698H, PUL402699H, PUL402700H, PUL402701H, PUL402702H, PUL402703H, PUL402704H, PUL402706H, PUL402707H, PUL402710H, PUL402712H, PUL402713H, PUL402714H, PUL402716H, PUL402717H, PUL402718H, PUL402719H, PUL402720H, PUL402723H, PUL402724H, PUL402726H, PUL402728H, PUL402731H, PUL402732H, PUL402734H, PUL402736H, PUL402737H, PUL402738H, PUL402739H, PUL402740H, PUL402741H, PUL402742H, PUL402743H, PUL402745H, PUL402746H, PUL402747H, PUL402748H, PUL402749H, PUL402753H, PUL402755H, PUL402756H, PUL402757H, PUL402758H, PUL402760H, PUL402763H, PUL402767H, PUL402769H, PUL402772H, PUL402776H, PUL402777H, PUL402779H, PUL402782H, PUL402785H, PUL402786H, PUL402787H, PUL402788H, PUL402790H, PUL402791H, PUL402792H, PUL402794H, PUL402795H, PUL402796H, PUL402802H, PUL402803H, PUL402805H, PUL402807H, PUL402808H, PUL402810H, PUL402811H, PUL402812H, PUL402813H, PUL402815H, PUL402818H, PUL402820H, PUL402821H, PUL402825H, PUL402826H, PUL402827H, PUL402828H, PUL402830H, PUL402832H, PUL402834H, PUL402835H, PUL402837H, PUL402838H, PUL402840H, PUL402841H, PUL402842H, PUL402843H, PUL402845H, PUL402847H, PUL402848H, PUL402849H, PUL402851H, PUL402852H, PUL402855H, PUL402857H, PUL402858H, PUL402860H, PUL402862H, PUL402864H, PUL402865H, PUL402866H, PUL402867H, PUL402868H, PUL402869H, PUL402870H, PUL402871H, PUL402872H, PUL402873H, PUL402874H, PUL402876H, PUL402878H, PUL402879H, PUL402880H, PUL402881H, PUL402882H, PUL402884H, PUL402885H, PUL402886H, PUL402887H, PUL402888H, PUL402890H, PUL402893H, PUL402895H, PUL402896H, PUL402897H, PUL402898H, PUL402900H, PUL402901H, PUL402902H, PUL402903H, PUL402904H, PUL402906H, PUL402907H, PUL402908H, PUL402909H, PUL402910H, PUL402911H, PUL402912H, PUL402915H, PUL402916H, PUL402917H, PUL402918H, PUL402919H, PUL402920H, PUL402922H, PUL402923H, PUL402924H, PUL402925H, PUL402926H, PUL402927H, PUL402928H, PUL402929H, PUL402930H, PUL402931H, PUL402932H, PUL402933H, PUL402936H, PUL402937H, PUL402938H, PUL402939H, PUL402940H, PUL402945H, PUL402947H, PUL402948H, PUL402949H, PUL402951H, PUL402952H, PUL402953H, PUL402954H, PUL402955H, PUL402956H, PUL402957H, PUL402959H, PUL402960H, PUL402961H, PUL402962H, PUL402964H, PUL402966H, PUL402967H, PUL402968H, PUL402969H, PUL402970H, PUL402971H, PUL402972H, PUL402975H, PUL402976H, PUL402977H, PUL402980H, PUL402981H, PUL402982H, PUL402983H, PUL402984H, PUL402990H, PUL402991H, PUL402992H, PUL402993H, PUL402995H, PUL402996H, PUL402998H, PUL402999H, PUL403000H, PUL403001H, PUL403002H, PUL403005H, PUL403006H, PUL403008H, PUL403011H, PUL403012H, PUL403013H, PUL403016H, PUL403018H, PUL403020H, PUL403021H, PUL403025H, PUL403026H, PUL403028H, PUL403029H, PUL403030H, PUL403031H, PUL403033H, PUL403034H, PUL403036H, PUL403037H, PUL403038H, PUL403039H, PUL403041H, PUL403042H, PUL403044H, PUL403045H, PUL403047H, PUL403048H, PUL403049H, PUL403052H, PUL403053H, PUL403054H, PUL403055H, PUL403057H, PUL403060H, PUL403061H, PUL403062H, PUL403063H, PUL403064H, PUL403065H, PUL403066H, PUL403068H, PUL403069H, PUL403070H, PUL403071H, PUL403073H, PUL403074H, PUL403075H, PUL403076H, PUL403077H, PUL403079H, PUL403080H, PUL403081H, PUL403082H, PUL403083H, PUL403084H, PUL403085H, PUL403086H, PUL403088H, PUL403089H, PUL403090H, PUL403091H, PUL403092H, PUL403093H, PUL403094H, PUL403095H, PUL403096H, PUL403097H, PUL403099H, PUL403100H, PUL403103H, PUL403104H, PUL403105H, PUL403106H, PUL403107H, PUL403108H, PUL403109H, PUL403110H, PUL403111H, PUL403112H, PUL403114H, PUL403116H, PUL403121H, PUL403123H, PUL403124H, PUL403126H, PUL403128H, PUL403130H, PUL403131H, PUL403133H, PUL403136H, PUL403138H, PUL403142H, PUL403143H, PUL403149H, PUL403150H, PUL403153H, PUL403154H, PUL403158H, PUL403160H, PUL403167H, PUL403168H, PUL403173H, PUL403175H, PUL403179H, PUL403181H, PUL403182H, PUL403186H, PUL403187H, PUL403189H, PUL403190H, PUL403191H, PUL403193H, PUL403196H, PUL403197H, PUL403199H, PUL403201H, PUL403202H, PUL403203H, PUL403207H, PUL403210H, PUL403211H, PUL403214H, PUL403215H, PUL403217H, PUL403218H, PUL403219H, PUL403220H, PUL403223H, PUL403225H, PUL403227H, PUL403229H, PUL403230H, PUL403231H, PUL403232H, PUL403233H, PUL403237H, PUL403238H, PUL403240H, PUL403241H, PUL403242H, PUL403243H, PUL403244H, PUL403245H, PUL403247H, PUL403248H, PUL403249H, PUL403251H, PUL403252H, PUL403253H, PUL403256H, PUL403257H, PUL403258H, PUL403259H, PUL403260H, PUL403263H, PUL403264H, PUL403265H, PUL403269H, PUL403271H, PUL403273H, PUL403275H, PUL403276H, PUL403278H, PUL403279H, PUL403280H, PUL403281H, PUL403283H, PUL403284H, PUL403285H, PUL403286H, PUL403288H, PUL403295H, PUL403300H, PUL403301H, PUL403306H, PUL403308H, PUL403311H, PUL403312H, PUL403313H, PUL403315H, PUL403318H, PUL403321H, PUL403323H, PUL403326H, PUL403329H, PUL403332H, PUL403333H, PUL403335H, PUL403337H, PUL403340H, PUL403341H, PUL403342H, PUL403343H, PUL403344H, PUL403350H, PUL403351H, PUL403352H, PUL403355H, PUL403356H, PUL403359H, PUL403360H, PUL403363H, PUL403364H, PUL403365H, PUL403366H, PUL403367H, PUL403370H, PUL403371H, PUL403373H, PUL403377H, PUL403379H, PUL403382H, PUL403384H, PUL403385H, PUL403386H, PUL403387H, PUL403388H, PUL403392H, PUL403393H, PUL403397H, PUL403401H, PUL403408H, PUL403409H, PUL403411H, PUL403413H, PUL403414H, PUL403415H, PUL403416H, PUL403417H, PUL403420H, PUL403422H, PUL403423H, PUL403424H, PUL403425H, PUL403427H, PUL403430H, PUL403432H, PUL403434H, PUL403435H, PUL403436H, PUL403438H, PUL403439H, PUL403440H, PUL403441H, PUL403444H, PUL403446H, PUL403447H, PUL403448H, PUL403450H, PUL403451H, PUL403453H, PUL403454H, PUL403455H, PUL403457H, PUL403458H, PUL403460H, PUL403462H, PUL403463H, PUL403464H, PUL403466H, PUL403467H, PUL403469H, PUL403470H, PUL403471H, PUL403473H, PUL403475H, PUL403476H, PUL403477H, PUL403478H, PUL403480H, PUL403481H, PUL403482H, PUL403483H, PUL403484H, PUL403485H, PUL403486H, PUL403488H, PUL403489H, PUL403492H, PUL403493H, PUL403495H, PUL403496H, PUL403498H, PUL403499H, PUL403500H, PUL403502H, PUL403503H, PUL403505H, PUL403506H, PUL403507H, PUL403508H, PUL403510H, PUL403511H, PUL403513H, PUL403514H, PUL403515H, PUL403517H, PUL403518H, PUL403519H, PUL403520H, PUL403521H, PUL403523H, PUL403524H, PUL403525H, PUL403526H, PUL403527H, PUL403528H, PUL403529H, PUL403530H, PUL403531H, PUL403532H, PUL403533H, PUL403535H, PUL403537H, PUL403540H, PUL403541H, PUL403542H, PUL403545H, PUL403546H, PUL403547H, PUL403548H, PUL403549H, PUL403551H, PUL403552H, PUL403554H, PUL403555H, PUL403556H, PUL403558H, PUL403559H, PUL403561H, PUL403563H, PUL403564H, PUL403565H, PUL403566H, PUL403568H, PUL403569H, PUL403570H, PUL403571H, PUL403572H, PUL403573H, PUL403574H, PUL403575H, PUL403576H, PUL403577H, PUL403578H, PUL403579H, PUL403580H, PUL403581H, PUL403582H, PUL403584H, PUL403585H, PUL403586H, PUL403587H, PUL403589H, PUL403590H, PUL403591H, PUL403593H, PUL403595H, PUL403597H, PUL403598H, PUL403599H, PUL403601H, PUL403602H, PUL403603H, PUL403605H, PUL403608H, PUL403609H, PUL403611H, PUL403613H, PUL403618H, PUL403620H, PUL403622H, PUL403623H, PUL403626H, PUL403629H, PUL403630H, PUL403631H, PUL403632H, PUL403634H, PUL403636H, PUL403637H, PUL403638H, PUL403642H, PUL403645H, PUL403646H, PUL403651H, PUL403654H, PUL403658H, PUL403659H, PUL403660H, PUL403662H, PUL403663H, PUL403664H, PUL403665H, PUL403666H, PUL403668H, PUL403669H, PUL403673H, PUL403675H, PUL403676H, PUL403678H, PUL403682H, PUL403683H, PUL403684H, PUL403685H, PUL403686H, PUL403687H, PUL403688H, PUL403690H, PUL403691H, PUL403692H, PUL403693H, PUL403694H, PUL403696H, PUL403701H, PUL403702H, PUL403704H, PUL403706H, PUL403708H, PUL403709H, PUL403711H, PUL403713H, PUL403716H, PUL403717H, PUL403718H, PUL403719H, PUL403720H, PUL403721H, PUL403722H, PUL403723H, PUL403724H, PUL403725H, PUL403726H, PUL403727H, PUL403729H, PUL403731H, PUL403733H, PUL403734H, PUL403735H, PUL403736H, PUL403737H, PUL403738H, PUL403739H, PUL403740H, PUL403743H, PUL403744H, PUL403745H, PUL403747H, PUL403749H, PUL403750H, PUL403752H, PUL403753H, PUL403754H, PUL403755H, PUL403756H, PUL403757H, PUL403759H, PUL403760H, PUL403763H, PUL403764H, PUL403766H, PUL403767H, PUL403768H, PUL403769H, PUL403771H, PUL403772H, PUL403773H, PUL403774H, PUL403775H, PUL403776H, PUL403777H, PUL403779H, PUL403781H, PUL403782H, PUL403783H, PUL403784H, PUL403785H, PUL403787H, PUL403788H, PUL403789H, PUL403790H, PUL403792H, PUL403793H, PUL403794H, PUL403795H, PUL403796H, PUL403797H, PUL403798H, PUL403799H, PUL403800H, PUL403801H, PUL403804H, PUL403806H, PUL403807H, PUL403809H, PUL403810H, PUL403811H, PUL403813H, PUL403814H, PUL403815H, PUL403816H, PUL403817H, PUL403819H, PUL403820H, PUL403821H, PUL403822H, PUL403824H, PUL403825H, PUL403827H, PUL403828H, PUL403829H, PUL403831H, PUL403832H, PUL403834H, PUL403836H, PUL403837H, PUL403838H, PUL403839H, PUL403840H, PUL403842H, PUL403843H, PUL403844H, PUL403845H, PUL403847H, PUL403848H, PUL403849H, PUL403850H, PUL403852H, PUL403854H, PUL403857H, PUL403858H, PUL403859H, PUL403860H, PUL403863H, PUL403866H, PUL403867H, PUL403868H, PUL403869H, PUL403870H, PUL403871H, PUL403872H, PUL403873H, PUL403874H, PUL403875H, PUL403876H, PUL403878H, PUL403879H, PUL403880H, PUL403882H, PUL403883H, PUL403884H, PUL403886H, PUL403887H, PUL403888H, PUL403889H, PUL403890H, PUL403891H, PUL403893H, PUL403894H, PUL403896H, PUL403897H, PUL403900H, PUL403902H, PUL403904H, PUL403905H, PUL403906H, PUL403907H, PUL403908H, PUL403909H, PUL403910H, PUL403911H, PUL403913H, PUL403914H, PUL403915H, PUL403917H, PUL403918H, PUL403919H, PUL403920H, PUL403922H, PUL403923H, PUL403924H, PUL403927H, PUL403928H, PUL403929H, PUL403931H, PUL403932H, PUL403934H, PUL403935H, PUL403936H, PUL403937H, PUL403938H, PUL403939H, PUL403940H, PUL403941H, PUL403942H, PUL403943H, PUL403945H, PUL403948H, PUL403949H, PUL403950H, PUL403951H, PUL403953H, PUL403955H, PUL403956H, PUL403957H, PUL403959H, PUL403960H, PUL403961H, PUL403962H, PUL403964H, PUL403965H, PUL403966H, PUL403967H, PUL403968H, PUL403969H, PUL403970H, PUL403971H, PUL403972H, PUL403973H, PUL403974H, PUL403975H, PUL403976H, PUL403977H, PUL403982H, PUL403983H, PUL403984H, PUL403987H, PUL403988H, PUL403989H, PUL403991H, PUL403992H, PUL403994H, PUL403995H, PUL403996H, PUL404002H, PUL404003H, PUL404011H, PUL404012H, PUL404013H, PUL404016H, PUL404018H, PUL404020H, PUL404022H, PUL404023H, PUL404025H, PUL404027H, PUL404029H, PUL404031H, PUL404035H, PUL404037H, PUL404039H, PUL404044H, PUL404045H, PUL404049H, PUL404051H, PUL404056H, PUL404057H, PUL404058H, PUL404062H, PUL404063H, PUL404064H, PUL404066H, PUL404067H, PUL404068H, PUL404071H, PUL404072H, PUL404073H, PUL404074H, PUL404079H, PUL404080H, PUL404081H, PUL404083H, PUL404085H, PUL404086H, PUL404087H, PUL404089H, PUL404090H, PUL404092H, PUL404093H, PUL404094H, PUL404097H, PUL404098H, PUL404100H, PUL404101H, PUL404105H, PUL404107H, PUL404109H, PUL404110H, PUL404112H, PUL404113H, PUL404114H, PUL404117H, PUL404118H, PUL404123H, PUL404129H, PUL404131H, PUL404133H, PUL404135H, PUL404141H, PUL404142H, PUL404143H, PUL404144H, PUL404145H, PUL404149H, PUL404150H, PUL404156H, PUL404157H, PUL404165H, PUL404172H, PUL404177H, PUL404178H, PUL404180H, PUL404181H, PUL404182H, PUL404183H, PUL404184H, PUL404185H, PUL404186H, PUL404187H, PUL404188H, PUL404189H, PUL404191H, PUL404193H, PUL404194H, PUL404195H, PUL404196H, PUL404197H, PUL404198H, PUL404199H, PUL404200H, PUL404201H, PUL404202H, PUL404205H, PUL404208H, PUL404209H, PUL404210H, PUL404211H, PUL404213H, PUL404217H, PUL404218H, PUL404219H, PUL404220H, PUL404221H, PUL404222H, PUL404223H, PUL404224H, PUL404225H, PUL404227H, PUL404228H, PUL404229H, PUL404231H, PUL404232H, PUL404234H, PUL404236H, PUL404238H, PUL404239H, PUL404240H, PUL404241H, PUL404242H, PUL404243H, PUL404244H, PUL404245H, PUL404246H, PUL404247H, PUL404248H, PUL404249H, PUL404250H, PUL404253H, PUL404254H, PUL404256H, PUL404257H, PUL404259H, PUL404260H, PUL404261H, PUL404262H, PUL404265H, PUL404266H, PUL404267H, PUL404269H, PUL404270H, PUL404271H, PUL404272H, PUL404273H, PUL404274H, PUL404275H, PUL404276H, PUL404278H, PUL404279H, PUL404280H, PUL404281H, PUL404282H, PUL404286H, PUL404287H, PUL404288H, PUL404289H, PUL404290H, PUL404291H, PUL404292H, PUL404295H, PUL404296H, PUL404297H, PUL404299H, PUL404300H, PUL404301H, PUL404302H, PUL404303H, PUL404304H, PUL404306H, PUL404308H, PUL404309H, PUL404310H, PUL404312H, PUL404313H, PUL404315H, PUL404318H, PUL404319H, PUL404321H, PUL404322H, PUL404323H, PUL404324H, PUL404325H, PUL404326H, PUL404327H, PUL404330H, PUL404332H, PUL404333H, PUL404334H, PUL404335H, PUL404336H, PUL404337H, PUL404338H, PUL404339H, PUL404340H, PUL404341H, PUL404343H, PUL404344H, PUL404345H, PUL404346H, PUL404347H, PUL404348H, PUL404349H, PUL404350H, PUL404351H, PUL404352H, PUL404354H, PUL404355H, PUL404357H, PUL404358H, PUL404362H, PUL404363H, PUL404365H, PUL404366H, PUL404369H, PUL404371H, PUL404373H, PUL404375H, PUL404376H, PUL404378H, PUL404379H, PUL404380H, PUL404381H, PUL404382H, PUL404383H, PUL404384H, PUL404385H, PUL404387H, PUL404388H, PUL404389H, PUL404390H, PUL404391H, PUL404393H, PUL404394H, PUL404395H, PUL404397H, PUL404399H, PUL404400H, PUL404402H, PUL404404H, PUL404405H, PUL404406H, PUL404407H, PUL404409H, PUL404410H, PUL404411H, PUL404412H, PUL404413H, PUL404414H, PUL404417H, PUL404418H, PUL404422H, PUL404425H, PUL404426H, PUL404428H, PUL404432H, PUL404433H, PUL404434H, PUL404435H, PUL404438H, PUL404439H, PUL404441H, PUL404442H, PUL404443H, PUL404445H, PUL404446H, PUL404447H, PUL404448H, PUL404449H, PUL404450H, PUL404452H, PUL404453H, PUL404454H, PUL404455H, PUL404456H, PUL404457H, PUL404458H, PUL404460H, PUL404462H, PUL404463H, PUL404465H, PUL404466H, PUL404467H, PUL404468H, PUL404469H, PUL404471H, PUL404472H, PUL404473H, PUL404474H, PUL404475H, PUL404476H, PUL404477H, PUL404481H, PUL404486H, PUL404487H, PUL404490H, PUL404492H, PUL404493H, PUL404494H, PUL404495H, PUL404496H, PUL404498H, PUL404499H, PUL404502H, PUL404503H, PUL404504H, PUL404505H, PUL404506H, PUL404509H, PUL404512H, PUL404515H, PUL404518H, PUL404519H, PUL404520H, PUL404521H, PUL404522H, PUL404523H, PUL404524H, PUL404525H, PUL404526H, PUL404527H, PUL404528H, PUL404530H, PUL404531H, PUL404533H, PUL404534H, PUL404537H, PUL404539H, PUL404540H, PUL404542H, PUL404544H, PUL404545H, PUL404547H, PUL404548H, PUL404549H, PUL404551H, PUL404556H, PUL404557H, PUL404558H, PUL404559H, PUL404560H, PUL404563H, PUL404564H, PUL404565H, PUL404566H, PUL404569H, PUL404570H, PUL404571H, PUL404572H, PUL404573H, PUL404574H, PUL404575H, PUL404576H, PUL404577H, PUL404578H, PUL404580H, PUL404581H, PUL404583H, PUL404584H, PUL404585H, PUL404587H, PUL404588H, PUL404590H, PUL404591H, PUL404592H, PUL404594H, PUL404595H, PUL404596H, PUL404597H, PUL404598H, PUL404605H, PUL404606H, PUL404609H, PUL404610H, PUL404611H, PUL404612H, PUL404613H, PUL404615H, PUL404616H, PUL404617H, PUL404620H, PUL404625H, PUL404626H, PUL404627H, PUL404629H, PUL404634H, PUL404637H, PUL404640H, PUL404642H, PUL404644H, PUL404652H, PUL404656H, PUL404658H, PUL404661H, PUL404662H, PUL404663H, PUL404671H, PUL404673H, PUL404674H, PUL404675H, PUL404676H, PUL404678H, PUL404681H, PUL404687H, PUL404689H, PUL404696H, PUL404697H, PUL404698H, PUL404702H, PUL404703H, PUL404704H, PUL404705H, PUL404706H, PUL404707H, PUL404708H, PUL404710H, PUL404711H, PUL404712H, PUL404713H, PUL404715H, PUL404716H, PUL404719H, PUL404720H, PUL404722H, PUL404723H, PUL404730H, PUL404731H, PUL404733H, PUL404734H, PUL404735H, PUL404738H, PUL404740H, PUL404741H, PUL404743H, PUL404744H, PUL404747H, PUL404748H, PUL404749H, PUL404750H, PUL404752H, PUL404755H, PUL404756H, PUL404757H, PUL404759H, PUL404760H, PUL404761H, PUL404762H, PUL404763H, PUL404764H, PUL404765H, PUL404766H, PUL404769H, PUL404770H, PUL404771H, PUL404772H, PUL404773H, PUL404774H, PUL404776H, PUL404778H, PUL404779H, PUL404781H, PUL404782H, PUL404783H, PUL404785H, PUL404786H, PUL404787H, PUL404788H, PUL404790H, PUL404791H, PUL404793H, PUL404794H, PUL404795H, PUL404797H, PUL404798H, PUL404799H, PUL404800H, PUL404802H, PUL404805H, PUL404807H, PUL404811H, PUL404813H, PUL404814H, PUL404815H, PUL404817H, PUL404819H, PUL404820H, PUL404826H, PUL404828H, PUL404830H, PUL404831H, PUL404832H, PUL404833H, PUL404834H, PUL404836H, PUL404838H, PUL404839H, PUL404840H, PUL404842H, PUL404843H, PUL404844H, PUL404846H, PUL404847H, PUL404849H, PUL404852H, PUL404853H, PUL404854H, PUL404856H, PUL404857H, PUL404859H, PUL404860H, PUL404861H, PUL404863H, PUL404864H, PUL404866H, PUL404868H, PUL404870H, PUL404871H, PUL404873H, PUL404874H, PUL404875H, PUL404876H, PUL404877H, PUL404878H, PUL404879H, PUL404880H, PUL404881H, PUL404886H, PUL404888H, PUL404891H, PUL404892H, PUL404893H, PUL404894H, PUL404895H, PUL404896H, PUL404897H, PUL404900H, PUL404901H, PUL404907H, PUL404909H, PUL404910H, PUL404914H, PUL404916H, PUL404918H, PUL404920H, PUL404921H, PUL404922H, PUL404924H, PUL404925H, PUL404926H, PUL404927H, PUL404928H, PUL404929H, PUL404931H, PUL404933H, PUL404935H, PUL404939H, PUL404944H, PUL404946H, PUL404949H, PUL404950H, PUL404951H, PUL404960H, PUL404961H, PUL404962H, PUL404963H, PUL404964H, PUL404965H, PUL404966H, PUL404967H, PUL404984H, PUL404994H, PUL404996H, PUL404997H, PUL404999H, PUL405001H, PUL405005H, PUL405008H, PUL405020H, PUL405024H, PUL405026H, PUL405028H, PUL405029H, PUL405030H, PUL405031H, PUL405032H, PUL405033H, PUL405034H, PUL405035H, PUL405037H, PUL405039H, PUL405041H, PUL405047H, PUL405048H, PUL405049H, PUL405050H, PUL405053H, PUL405054H, PUL405057H, PUL405059H, PUL405062H, PUL405065H, PUL405070H, PUL405075H, PUL405076H, PUL405087H, PUL405088H, PUL405090H, PUL405092H, PUL405095H, PUL405106H, PUL405109H, PUL405110H, PUL405111H, PUL405112H, PUL405115H, PUL405117H, PUL405118H, PUL405121H, PUL405124H, PUL405128H, PUL405130H, PUL405131H, PUL405137H, PUL405138H, PUL405143H, PUL405156H, PUL405158H, PUL405169H, PUL405173H, PUL405174H, PUL405180H, PUL405189H, PUL405190H, PUL405191H, PUL405193H, PUL405195H, PUL405199H, PUL405201H, PUL405206H, PUL405209H, PUL405211H, PUL405215H, PUL405216H, PUL405219H, PUL405220H, PUL405222H, PUL405235H, PUL405242H, PUL405247H, PUL405251H, PUL405253H, PUL405254H, PUL405257H, PUL405262H, PUL405267H, PUL405276H, PUL405281H, PUL405284H, PUL405286H, PUL405297H, PUL405300H, PUL405303H, PUL405305H, PUL405307H, PUL405310H, PUL405319H, PUL405320H, PUL405325H, PUL405331H, PUL405333H, PUL405340H, PUL405342H, PUL405355H, PUL405356H, PUL405357H, PUL405360H, PUL405361H, PUL405371H, PUL405378H, PUL405383H, PUL405396H, PUL405397H, PUL405402H, PUL405416H, PUL405422H, PUL405426H, PUL405427H, PUL405433H, PUL405443H, PUL405445H, PUL405447H, PUL405448H, PUL405451H, PUL405452H, PUL405455H, PUL405460H, PUL405461H, PUL405475H, PUL405481H, PUL405490H, PUL405493H, PUL405499H, PUL405509H, PUL405516H, PUL405520H, PUL405524H, PUL405527H, PUL405528H, PUL405529H, PUL405534H, PUL405535H, PUL405536H, PUL405538H, PUL405539H, PUL405540H, PUL405542H, PUL405544H, PUL405546H, PUL405549H, PUL405550H, PUL405551H, PUL405554H, PUL405556H, PUL405557H, PUL405558H, PUL405560H, PUL405561H, PUL405562H, PUL405564H, PUL405566H, PUL405567H, PUL405568H, PUL405569H, PUL405570H, PUL405573H, PUL405574H, PUL405576H, PUL405577H, PUL405578H, PUL405580H, PUL405582H, PUL405583H, PUL405585H, PUL405591H, PUL405592H, PUL405594H, PUL405595H, PUL405596H, PUL405598H, PUL405599H, PUL405602H, PUL405603H, PUL405605H, PUL405606H, PUL405607H, PUL405609H, PUL405613H, PUL405615H, PUL405618H, PUL405623H, PUL405624H, PUL405625H, PUL405629H, PUL405633H, PUL405637H, PUL405643H, PUL405647H, PUL405648H, PUL405652H, PUL405654H, PUL405658H, PUL405660H, PUL405661H, PUL405662H, PUL405664H, PUL405668H, PUL405669H, PUL405670H, PUL405671H, PUL405675H, PUL405676H, PUL405677H, PUL405679H, PUL405680H, PUL405681H, PUL405686H, PUL405689H, PUL405690H, PUL405691H, PUL405693H, PUL405695H, PUL405698H, PUL405700H, PUL405703H, PUL405704H, PUL405708H, PUL405709H, PUL405710H, PUL405714H, PUL405715H, PUL405716H, PUL405717H, PUL405719H, PUL405720H, PUL405727H, PUL405728H, PUL405734H, PUL405735H, PUL405737H, PUL405738H, PUL405739H, PUL405742H, PUL405748H, PUL405749H, PUL405753H, PUL405757H, PUL405763H, PUL405764H, PUL405768H, PUL405771H, PUL405772H, PUL405783H, PUL405788H, PUL405790H, PUL405809H, PUL405810H, PUL405813H, PUL405814H, PUL405816H, PUL405817H, PUL405819H, PUL405820H, PUL405821H, PUL405824H, PUL405825H, PUL405826H, PUL405827H, PUL405828H, PUL405833H, PUL405839H, PUL405843H, PUL405845H, PUL405847H, PUL405850H, PUL405852H, PUL405855H, PUL405856H, PUL405857H, PUL405859H, PUL405860H, PUL405861H, PUL405862H, PUL405863H, PUL405864H, PUL405867H, PUL405870H, PUL405872H, PUL405873H, PUL405874H, PUL405875H, PUL405876H, PUL405877H, PUL405879H, PUL405881H, PUL405882H, PUL405883H, PUL405885H, PUL405887H, PUL405890H, PUL405893H, PUL405897H, PUL405899H, PUL405902H, PUL405903H, PUL405906H, PUL405908H, PUL405909H, PUL405911H, PUL405912H, PUL405913H, PUL405914H, PUL405919H, PUL405926H, PUL405927H, PUL405931H, PUL405932H, PUL405939H, PUL405940H, PUL405941H, PUL405942H, PUL405947H, PUL405949H, PUL405952H, PUL405958H, PUL405963H, PUL405967H, PUL405969H, PUL405971H, PUL405972H, PUL405973H, PUL405982H, PUL406002H, PUL406007H, PUL406009H, PUL406010H, PUL406027H, PUL406028H, PUL406029H, PUL406030H, PUL406031H, PUL406034H, PUL406036H, PUL406038H, PUL406047H, PUL406049H, PUL406051H, PUL406053H, PUL406056H, PUL406057H, PUL406058H, PUL406061H, PUL406063H, PUL406071H, PUL406073H, PUL406074H, PUL406077H, PUL406079H, PUL406081H, PUL406086H, PUL406104H, PUL406107H, PUL406111H, PUL406114H, PUL406118H, PUL406124H, PUL406127H, PUL406137H, PUL406142H, PUL406143H, PUL406146H, PUL406148H, PUL406150H, PUL406155H, PUL406159H, PUL406163H, PUL406166H, PUL406168H, PUL406171H, PUL406177H, PUL406179H, PUL406187H, PUL406188H, PUL406190H, PUL406191H, PUL406195H, PUL406200H, PUL406203H, PUL406204H, PUL406205H, PUL406207H, PUL406213H, PUL406218H, PUL406226H, PUL406229H, PUL406231H, PUL406232H, PUL406237H, PUL406238H, PUL406248H, PUL406255H, PUL406271H, PUL406289H, PUL406312H, PUL406367H, PUL406376H, PUL406382H, PUL406384H, PUL406388H, PUL406391H, PUL406392H, PUL406398H, PUL406399H, PUL406400H, PUL406403H, PUL406405H, PUL406406H, PUL406407H, PUL406410H, PUL406411H, PUL406414H, PUL406415H, PUL406417H, PUL406418H, PUL406419H, PUL406420H, PUL406424H, PUL406432H, PUL406436H, PUL406437H, PUL406438H, PUL406439H, PUL406440H, PUL406446H, PUL406447H, PUL406453H, PUL406454H, PUL406456H, PUL406457H, PUL406462H, PUL406466H, PUL406467H, PUL406469H, PUL406470H, PUL406472H, PUL406475H, PUL406479H, PUL406483H, PUL406484H, PUL406486H, PUL406552H, PUL406587H, PUL406593H, PUL406594H, PUL406602H, PUL406603H, PUL406607H, PUL406609H, PUL406610H, PUL406614H, PUL406615H, PUL406621H, PUL406622H, PUL406623H, PUL406625H, PUL406630H, PUL406632H, PUL406633H, PUL406635H, PUL406638H, PUL406643H, PUL406652H, PUL406654H, PUL406658H, PUL406661H, PUL406662H, PUL406667H, PUL406672H, PUL406703H, PUL406706H, PUL406715H, PUL406716H, PUL406720H, PUL406730H, PUL406741H, PUL406749H, PUL406752H, PUL406754H, PUL406757H, PUL406760H, PUL406761H, PUL406764H, PUL406768H, PUL406769H, PUL406770H, PUL406771H, PUL406772H, PUL406777H, PUL406781H, PUL406782H, PUL406790H, PUL406798H, PUL406804H, PUL406806H, PUL406808H, PUL406809H, PUL406841H, PUL406842H, PUL406845H, PUL406848H, PUL406858H, PUL406863H, PUL406864H, PUL406867H, PUL406874H, PUL406879H, PUL406886H, PUL406896H, PUL406897H, PUL406898H, PUL406901H, PUL406902H, PUL406909H, PUL406913H, PUL406920H, PUL406925H, PUL406928H, PUL406931H, PUL406933H, PUL406939H, PUL406942H, PUL406947H, PUL406948H, PUL406949H, PUL406955H, PUL406958H, PUL406973H, PUL406974H, PUL406989H, PUL406992H, PUL407000H, PUL407001H, PUL407006H, PUL407008H, PUL407011H, PUL407013H, PUL407014H, PUL407029H, PUL407035H, PUL407040H, PUL407044H, PUL407045H, PUL407050H, PUL407052H, PUL407058H, PUL407068H, PUL407076H, PUL407081H, PUL407086H, PUL407090H, PUL407099H, PUL410353H, PUL412089H, PUL412881H, PUL415125H, PUL438812H, PUL440753H, PUL441763H;

4) Serial numbers: PUN400013H, PUN400015H, PUN400016H, PUN400034H, PUN400036H, PUN400039H, PUN402922H, PUN402926H, PUN415316H, PUN416223H;

5) Serial numbers: PVV600002S, PVV600003S, PVV600005S, PVV600008S, PVV600009S, PVV600010S, PVV600011S, PVV600013S, PVV600015S, PVV600016S, PVV600017S, PVV600018S, PVV600019S, PVV600020S, PVV600022S, PVV600023S, PVV600027S, PVV600028S, PVV600029S, PVV600030S, PVV600031S, PVV600033S, PVV600035S, PVV600036S, PVV600038S, PVV600040S, PVV600041S, PVV600043S, PVV600044S, PVV600045S, PVV600046S, PVV600047S, PVV600048S, PVV600049S, PVV600050S, PVV600054S, PVV600055S, PVV600056S, PVV600057S, PVV600058S, PVV600059S, PVV600060S, PVV600061S, PVV600062S, PVV600063S, PVV600064S, PVV600065S, PVV600066S, PVV600067S, PVV600069S, PVV600070S, PVV600071S, PVV600072S, PVV600073S, PVV600075S, PVV600076S, PVV600078S, PVV600079S, PVV600080S, PVV600082S, PVV600083S, PVV600084S, PVV600087S, PVV600088S, PVV600089S, PVV600090S, PVV600091S, PVV600092S, PVV600093S, PVV600094S, PVV600096S, PVV600097S, PVV600098S, PVV600100S, PVV600102S, PVV600103S, PVV600104S, PVV600105S, PVV600106S, PVV600107S, PVV600108S, PVV600109S, PVV600110S, PVV600111S, PVV600112S, PVV600114S, PVV600115S, PVV600116S, PVV600117S, PVV600118S, PVV600119S, PVV600120S, PVV600122S, PVV600124S, PVV600125S, PVV600126S, PVV600128S, PVV600129S, PVV600130S, PVV600131S, PVV600133S, PVV600134S, PVV600137S, PVV600138S, PVV600139S, PVV600140S, PVV600141S, PVV600142S, PVV600143S, PVV600144S, PVV600146S, PVV600147S, PVV600148S, PVV600149S, PVV600150S, PVV600151S, PVV600153S, PVV600154S, PVV600156S, PVV600157S, PVV600158S, PVV600159S, PVV600161S, PVV600162S, PVV600163S, PVV600164S, PVV600180S, PVV600184S, PVV600185S, PVV600188S, PVV600195S, PVV600199S, PVV600202S, PVV600203S, PVV600207S, PVV600214S, PVV600215S, PVV600216S, PVV600217S, PVV600218S, PVV600219S, PVV600221S, PVV600222S, PVV600223S, PVV600224S, PVV600226S, PVV600227S, PVV600228S, PVV600230S, PVV600232S, PVV600233S, PVV600234S, PVV600235S, PVV600236S, PVV600237S, PVV600238S, PVV600246S, PVV600251S, PVV600263S, PVV600265S, PVV600267S, PVV600268S, PVV600270S, PVV600272S, PVV600273S, PVV600281S, PVV600284S, PVV600288S, PVV600296S, PVV600302S, PVV600303S, PVV600315S, PVV600322S, PVV600331S, PVV600332S, PVV600334S, PVV600337S, PVV600339S, PVV600349S, PVV600350S, PVV600351S, PVV600352S, PVV600354S, PVV600355S, PVV600356S, PVV600359S, PVV600360S, PVV600363S, PVV600364S, PVV600379S, PVV600380S, PVV600383S, PVV600392S, PVV600394S, PVV600397S, PVV600400S, PVV600405S, PVV600408S, PVV600410S, PVV600414S, PVV600419S, PVV600420S, PVV600433S, PVV600437S, PVV600439S, PVV600442S, PVV600445S, PVV600446S, PVV600448S, PVV600450S, PVV600452S, PVV600453S, PVV600458S, PVV600461S, PVV600464S, PVV600465S, PVV600467S, PVV600471S, PVV600479S, PVV600485S, PVV600491S, PVV600495S, PVV600501S, PVV600503S, PVV600504S, PVV600505S, PVV600507S, PVV600508S, PVV600512S, PVV600516S, PVV600518S, PVV600521S, PVV600526S, PVV600527S, PVV600530S, PVV600535S, PVV600548S, PVV600554S, PVV600557S, PVV600560S, PVV600567S, PVV600572S, PVV600578S, PVV600579S, PVV600583S, PVV600585S, PVV600587S, PVV600588S, PVV600591S, PVV600597S, PVV600600S, PVV600603S, PVV600605S, PVV600606S, PVV600612S, PVV600613S, PVV600614S, PVV600615S, PVV600616S, PVV600617S, PVV600623S, PVV600624S, PVV600635S, PVV600641S, PVV600642S, PVV600643S, PVV600646S, PVV600647S, PVV600649S, PVV600651S, PVV600656S, PVV600660S, PVV600661S, PVV600669S, PVV600670S, PVV600675S, PVV600679S, PVV600681S, PVV600693S, PVV600694S, PVV600707S, PVV600709S, PVV600710S, PVV600718S, PVV600722S, PVV600724S, PVV600727S, PVV600729S, PVV600730S, PVV600732S, PVV600733S, PVV600740S, PVV600742S, PVV600751S, PVV600768S, PVV600786S, PVV600787S, PVV600793S, PVV600795S, PVV600803S, PVV600810S, PVV600820S, PVV600824S, PVV600842S, PVV600846S, PVV600850S, PVV600855S, PVV600863S, PVV600871S, PVV600874S, PVV600875S, PVV600880S, PVV600881S, PVV600888S, PVV600896S, PVV600898S, PVV600899S, PVV600900S, PVV600901S, PVV600902S, PVV600903S, PVV600904S, PVV600905S, PVV600906S, PVV600907S, PVV600909S, PVV600910S, PVV600912S, PVV600913S, PVV600914S, PVV600915S, PVV600916S, PVV600918S, PVV600919S, PVV600920S, PVV600922S, PVV600923S, PVV600924S, PVV600925S, PVV600926S, PVV600927S, PVV600928S, PVV600930S, PVV600932S, PVV600933S, PVV600936S, PVV600940S, PVV600941S, PVV600944S, PVV600946S, PVV600951S, PVV600954S, PVV600960S, PVV600961S, PVV600963S, PVV600965S, PVV600970S, PVV600976S, PVV600981S, PVV600984S, PVV600986S, PVV600990S, PVV600993S, PVV600995S, PVV600999S, PVV601005S, PVV601016S, PVV601027S, PVV601034S, PVV601086S, PVV601089S, PVV601092S, PVV601097S, PVV601102S, PVV601111S, PVV601112S, PVV601113S, PVV601130S, PVV601132S, PVV601134S, PVV601136S, PVV601141S, PVV601147S, PVV601150S, PVV601151S, PVV601156S, PVV601159S, PVV601163S, PVV601169S, PVV601174S, PVV601175S, PVV601181S, PVV601196S, PVV601202S, PVV601204S, PVV601222S, PVV601223S, PVV601224S, PVV601225S, PVV601226S, PVV601227S, PVV601228S, PVV601229S, PVV601230S, PVV601231S, PVV601232S, PVV601233S, PVV601234S, PVV601235S, PVV601236S, PVV601239S, PVV601242S, PVV601243S, PVV601244S, PVV601245S, PVV601252S, PVV601256S, PVV601286S, PVV601292S, PVV601343S, PVV601344S, PVV601350S, PVV601355S, PVV601358S, PVV601362S, PVV603655S, PVV603658S, PVV603660S, PVV603670S

6) Serial numbers: PUP600014S, PUP600018S, PUP600021S, PUP600022S, PUP600026S, PUP600028S, PUP600030S, PUP600032S, PUP600052S, PUP600063S, PUP600070S, PUP600077S, PUP600078S, PUP600079S, PUP600082S, PUP600087S, PUP600092S, PUP600095S, PUP600096S, PUP600098S, PUP600107S, PUP600115S, PUP600118S, PUP600120S, PUP600121S, PUP600122S, PUP600126S, PUP600128S, PUP600129S, PUP600130S, PUP600132S, PUP600133S, PUP600135S, PUP600138S, PUP600139S, PUP600140S, PUP600141S, PUP600142S, PUP600144S, PUP600146S, PUP600149S, PUP600153S, PUP600156S, PUP600159S, PUP600163S, PUP600164S, PUP600166S, PUP600167S, PUP600169S, PUP600170S, PUP600172S, PUP600174S, PUP600176S, PUP600177S, PUP600180S, PUP600185S, PUP600187S, PUP600188S, PUP600193S, PUP600195S, PUP600199S, PUP600200S, PUP600201S, PUP600203S, PUP600205S, PUP600207S, PUP600210S, PUP600212S, PUP600214S, PUP600215S, PUP600216S, PUP600217S, PUP600218S, PUP600220S, PUP600221S, PUP600224S, PUP600227S, PUP600228S, PUP600229S, PUP600231S, PUP600234S, PUP600247S, PUP600254S, PUP600255S, PUP600256S, PUP600257S, PUP600263S, PUP600266S, PUP600271S, PUP600274S, PUP600278S, PUP600279S, PUP600283S, PUP600285S, PUP600291S, PUP600293S, PUP600298S, PUP600299S, PUP600303S, PUP600320S, PUP600325S, PUP600326S, PUP600328S, PUP600332S, PUP600336S, PUP600340S, PUP600342S, PUP600343S, PUP600344S, PUP600346S, PUP600349S, PUP600354S, PUP600360S, PUP600364S, PUP600368S, PUP600373S, PUP600374S, PUP600375S, PUP600377S, PUP600381S, PUP600382S, PUP600384S, PUP600385S, PUP600390S, PUP600391S, PUP600395S, PUP600396S, PUP600398S, PUP600413S, PUP600424S, PUP600427S, PUP600439S, PUP600441S, PUP600442S, PUP600446S, PUP600448S, PUP600455S, PUP600457S, PUP600458S, PUP600460S, PUP600461S, PUP600462S, PUP600465S, PUP600468S, PUP600469S, PUP600474S, PUP600475S, PUP600477S, PUP600484S, PUP600485S, PUP600496S, PUP600498S, PUP600511S, PUP600516S, PUP600518S, PUP600523S, PUP600524S, PUP600529S, PUP600531S, PUP600532S, PUP600533S, PUP600539S, PUP600540S, PUP600544S, PUP600546S, PUP600554S, PUP600557S, PUP600562S, PUP600565S, PUP600566S, PUP600573S, PUP600576S, PUP600580S, PUP600586S, PUP600589S, PUP600590S, PUP600593S, PUP600598S, PUP600599S, PUP600602S, PUP600613S, PUP600615S, PUP600620S, PUP600621S, PUP600631S, PUP600632S, PUP600636S, PUP600637S, PUP600639S, PUP600641S, PUP600642S, PUP600646S, PUP600648S, PUP600653S, PUP600660S, PUP600662S, PUP600663S, PUP600670S, PUP600675S, PUP600680S, PUP600693S, PUP600696S, PUP600697S, PUP600703S, PUP600704S, PUP600706S, PUP600707S, PUP600708S, PUP600713S, PUP600720S, PUP600725S, PUP600727S, PUP600728S, PUP600731S, PUP600734S, PUP600736S, PUP600740S, PUP600742S, PUP600743S, PUP600744S, PUP600745S, PUP600747S, PUP600749S, PUP600751S, PUP600753S, PUP600760S, PUP600766S, PUP600769S, PUP600771S, PUP600773S, PUP600791S, PUP600792S, PUP600793S, PUP600799S, PUP600802S, PUP600804S, PUP600805S, PUP600807S, PUP600808S, PUP600810S, PUP600812S, PUP600814S, PUP600816S, PUP600819S, PUP600820S, PUP600822S, PUP600823S, PUP600824S, PUP600828S, PUP600831S, PUP600832S, PUP600834S, PUP600836S, PUP600839S, PUP600851S, PUP600855S, PUP600858S, PUP600867S, PUP600869S, PUP600871S, PUP600897S, PUP600898S, PUP600901S, PUP600914S, PUP600918S, PUP600924S, PUP600926S, PUP600933S, PUP600937S, PUP600938S, PUP600946S, PUP600956S, PUP600964S, PUP600973S, PUP600995S, PUP600999S, PUP601001S, PUP601004S, PUP601005S, PUP601011S, PUP601012S, PUP601014S, PUP601016S, PUP601017S, PUP601041S, PUP601044S, PUP601048S, PUP601057S, PUP601059S, PUP601060S, PUP601065S, PUP601076S, PUP601083S, PUP601088S, PUP601089S, PUP601099S, PUP601103S, PUP601104S, PUP601105S, PUP601107S, PUP601109S, PUP601110S, PUP601116S, PUP601118S, PUP601125S, PUP601129S, PUP601130S, PUP601131S, PUP601132S, PUP601135S, PUP601139S, PUP601140S, PUP601141S, PUP601142S, PUP601145S, PUP601146S, PUP601153S, PUP601161S, PUP601168S, PUP601169S, PUP601175S, PUP601181S, PUP601187S, PUP601190S, PUP601195S, PUP601198S, PUP601219S, PUP601220S, PUP601231S, PUP601233S, PUP601236S, PUP601260S, PUP601263S, PUP601268S, PUP601277S, PUP601283S, PUP601285S, PUP601286S, PUP601300S, PUP601304S, PUP601305S, PUP601306S, PUP601309S, PUP601310S, PUP601314S, PUP601318S, PUP601325S, PUP601326S, PUP601328S, PUP601334S, PUP601363S, PUP601368S, PUP601370S, PUP601373S, PUP601374S, PUP601375S, PUP601378S, PUP601379S, PUP601383S, PUP601384S, PUP601390S, PUP601400S, PUP601401S, PUP601402S, PUP601407S, PUP601409S, PUP601411S, PUP601412S, PUP601416S, PUP601417S, PUP601418S, PUP601419S, PUP601421S, PUP601422S, PUP601423S, PUP601432S, PUP601434S, PUP601440S, PUP601441S, PUP601442S, PUP601443S, PUP601444S, PUP601446S, PUP601447S, PUP601448S, PUP601449S, PUP601450S, PUP601451S, PUP601452S, PUP601458S, PUP601459S, PUP601460S, PUP601461S, PUP601462S, PUP601463S, PUP601464S, PUP601465S, PUP601466S, PUP601467S, PUP601470S, PUP601483S, PUP601502S, PUP601509S, PUP601510S, PUP601512S
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc., Cardiac Rhythm Disease Management, Saint Paul, MN,
Manufacturers: Medtronic Swiss Manufacturing Facility, Tolochenaz, Switzerland and
Medtronic Puerto Rico Operations Company (MPROC), Juncos, Puerto Rico.
REASON
A subset of active implanted Concerto CRT-D and Virtuoso ICD devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. This issue may present in the affected devices as reaching the Recommended Replacement Time (RRT) earlier than projected. This issue does not compromise device functionality or affect therapy delivery. Medtronic expects that affected devices will continue to provide at least three months of normal device function between RRT and End of Service (EOS) as described in device labeling.
VOLUME OF PRODUCT IN COMMERCE
6,284 units
DISTRIBUTION Nationwide (except ID and WY) Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabia, Spain, Sweden, Switzerland, Turkey and United Kingdom

PRODUCT Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl. oz. (355 ml). Product is used for the cleaning, rinsing, disinfecting, and storage of soft contact lenses.
CODE Lot # GA8028
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Bausch & Lomb, Inc., Rochester, NY,
Manufacturer: Bausch & Lomb, Inc., Greenville, SC.
REASON
During routine testing the product failed to meet shelf life specifications.
VOLUME OF PRODUCT IN COMMERCE
5,000/12 oz bottles
DISTRIBUTION Nationwide, Trinidad, St. Croix, St. Thomas, Aruba and Bermuda

PRODUCT 
* (Box label) Suction Coagulator 10FR Qty 25 ***** * (Pouch label) Ultraclean TM Foot Controlled Suction Coagulator 10 FR Qty: 1 ** Sterile ***** Made in China.
CODE Lot # 09GHL001 July 2014
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConMed Electrosurgery, Centennial, CO,
Manufacturer: Modern Metal & Electric Ltd., Kwai Chung, Hong Kong SAR.
REASON
One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
VOLUME OF PRODUCT IN COMMERCE
2,700
DISTRIBUTION Nationwide

PRODUCT 
1) Koordinat M/MP Patient Table used with Angiostar Model 5294009. The device is used as an Angiographic X-Ray System.

2) Koordinat M/MP Patient Table used with Multistar Model 6239003. The device is used as an Angiographic X-Ray System.
CODE
1) Serial numbers: 1001, 1004, 1017, 1019, 1024, 1029, 1033, 1038, 1040, 1042, 1048, 1055, 1056, 1060, 1062, 1066, 1067, 1070, 1075, 1083, 1085, 1088, 1090, 1092, 1093, 1094, 1101, 1102, 1103, 1104, 1105, 1107, 1108, 1113, 1115, 1116, 1117, 1119, 1123, 1126, 1127, 1130, 1134, 1138, 1143, 1144, 1146, 1147, 1148, 1149, 1152, 1157, 1158, 1160, 1166, 1167, 1173, 1177, 1178, 1180, 1184, 1186, 1192, 1196, 1207, 1213, 1214, 1216, 1217, 1226, 1229, 1231, 1233, 1234, 1235, 1236, 1237, 1238, 1240, 1245, 1247, 1248, 1250, 1256, 1262, 1263, 1265, 1266, 1281, 1283, 1289, 1290, 1292, 1293, 1294, 1296, 1297, 1300, 1302, 1303, 1305, 1308, 1312, 1314, 1319, 1321, and 1322;

2) Serial numbers: 1024, 1036, 1050, 1051, 1054, 1058, 1071, 1072, 1076, 1087, 1093, 1094, 1095, 1098, 1109, 1110, 1112, 1120, 1123, 1128, 1133, 1150, 1151, 1162, 1177, 1179, 1189, 1190, 1194, 1199, 1206, 1209, 1215, 1222, 1230, 1231, 1247, 1250, 1254, 1256, 1265, 1275, 1279, 1285, 1292, 1296, 1297, 1298, 1303, 1305, 1306, 1307, 1309, 1310, 1313, 1319, 1320, 1322, 1331, 1335, 1336, 1341, 1344, 1347, 1348, 1350, 1354, 1358, 1361, 1365, 1369, 1375, 1389, 1390, 1401, 1405, 1411, 1418, 1422, 1426, 1429, 1431, 1436, 1441, 1447, 1448, 1451, 1457, 1462, 1464, 1467, 1478, 1485, 1497, 1498, 1501, 1504, 1512, 1513, 1517, 1518, 1520, 1522, 1524, 1534, 1537, 1543, 1548, 1550, 1552, 1556, 1557, 1559, 1564, 1566, 1569, 1570, 1573, 1577, 1581, 1587, 1590, 1605, 1607, 1615, 1617, 1618, 1619, 1620, 1626, 1628, 1632, 1634, 1650, 1657, 1663, 1664, 1666, 1670, 1674, 1682, 1689, 1701, 1708, 1711, 1716, 1718, 1720, 1722, 1727, 1728, 1731, 1732, 1740, 1744, 1751, 1754, 1756, 1757, 1761, 1768, 1771, 1776, 1777, 1779, 1780, 1781, 1783, 1784, 1789, 1792, 1794, 1801, 1803, 1805, 1810, 1813, 1817, 1819, 1820, 1821, 1822, 1824, 1829, 1832, 1835, 1841, 1844, 1847, 1850, 1851, 1852, 1858, 1865, 1866, 1867, 1871, 1873, 1875, 1877, 1879, 1880, 1881, 1886, 1888, 1890, 1895, 1896, 1906, 1908, 1915, 1918, 1923, 1924, 1925, 1926, 1932, 1934, 1938, 1942, 1952, 1954, 1962, 1976, 1981, 1984, 1989, 1998, 2003, 2007, 2008, 2009, 2013, 2015, 2016, 2017, 2021, 2024, 2025, 2028, 2035, 2040, 2041, 2042, 2044, 2053, 2055, 2060, 2061, 2068, 2071, 2074, 2076, 2078, 2079, 2080, 2082, 2084, 2085, 2089, 2092, 2095, 2096, 2100, 2104, 2107, 2118, 2120, 2121, 2123, 2124, 2125, 2126, 2127, 2128, 2129, 2140, 2143, 2146, 2162, 2163, 2170, 2177, 2179, 2181, 2183, 2184, 2194, 2196, 2200, 2202, 2212, 2213, 2215, 2218, 2219, 2223, 2225, 2227, 2228, 2230, 2231, 2235, 2238, 2244, 2246, 2248, 2253, 2254, 2256, 2258, 2261, 2263, 2266, 2267, 2271, 2277, 2280, 2294, 2300, 2301, 2318, 2323, 2324, 2326, 2329, 2335, 2336, 2341, 2344, 2346, 2347, 2348, 2350, 2351, 2352, 2353, 2357, 2359, 2361, 2368, 2372,2376, 2378, 2380, 2381, 2388, 2390, 2391, 2392, 2394, 2398, 2399, 2401, 2403, 2418, 2461, 2507, 2690, 2742, 3426, 4995, and 11714
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany.
REASON
The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
VOLUME OF PRODUCT IN COMMERCE
469 units
DISTRIBUTION Nationwide

PRODUCT Gynecare Morcellex Tissue Morcellator. a) Product Code: MX0100 Hand Piece - 5 pack; b) Product Code: MX0100R- single.
CODE
a) Lot numbers: MT212363 10/1/2009 MT212369 10/1/2009 MT212372 10/1/2009 MT212378 10/1/2009 MT212385 10/1/2009 MT212392 10/31/2009 MT212403 10/1/2009 MT212422 10/1/2009 MT212427 10/1/2009 MT212432 10/1/2009 MT212446 10/31/2009 MT212450 10/1/2009 MT212463 10/1/2009 MT212475 11/1/2009 MT212485 11/1/2009 MT212493 11/1/2009 MT212497 11/1/2009 MT212501 11/1/2009 MT212509 11/1/2009 MT212518 11/1/2009 MT212527 11/1/2009 MT212539 11/1/2009 MT212553 12/1/2009 MT212577 12/1/2009 MT212585 12/31/2009 MT212591 12/31/2009 MT212602 12/31/2009 MT212610 12/1/2009 MT212616 12/1/2009 MT212621 12/1/2009 MT212627 12/31/2009 MT212633 12/31/2009 MT212637 12/31/2009 MT212655 1/31/2010 MT212661 1/31/2010 MT212666 1/31/2010 MT212673 1/31/2010 MT212680 1/31/2010 MT212702 1/31/2010 MT212708 1/31/2010 MT212712 1/31/2010 MT212718 1/31/2010 MT212723 1/31/2010 MT212732 2/1/2010 MT212745 2/1/2010 MT212758 2/1/2010 MT212762 2/1/2010 MT212772 2/1/2010 MT212776 2/28/2010 MT212787 2/28/2010 MT212797 2/1/2010 MT212815 2/1/2010 MT212818 2/1/2010 MT212829 2/1/2010 MT212841 3/1/2010 MT212850 3/1/2010 MT212857 3/1/2010 MT212871 3/31/2010 MT212895 3/1/2010 MT212901 3/31/2010 MT212912 3/31/2010 MT212920 3/31/2010 MT212924 3/31/2010 MT212931 3/1/2010 MT212938 3/31/2010 MT212942 3/1/2010 MT212956 4/30/2010 MT212969 4/30/2010 MT212976 4/30/2010 MT212982 4/20/2010 MT212987 4/30/2010 MT212994 4/30/2010 MT213004 4/30/2010 MT213011 4/30/2010 MT213018 4/30/2010 MT213024 4/30/2010 MT213038 4/30/2010 MT213044 4/1/2010 MT213059 5/1/2010 MT213064 5/31/2010 MT213073 5/31/2010 MT213076 5/30/2010 MT213082 5/31/2010 MT213090 5/1/2010 MT213096 5/30/2010 MT213103 5/31/2010 MT213111 5/31/2010 MT213117 5/1/2010 MT213122 5/30/2010 MT213126 5/31/2010 MT213140 6/30/2010 MT213143 6/30/2010 MT213155 6/30/2010 MT213165 6/30/2010 MT213169 6/30/2010 MT213173 6/30/2010 MT213180 6/30/2010 MT213191 6/30/2010 MT213195 6/30/2010 MT213198 6/30/2010 MT213203 6/30/2010 MT213209 6/30/2010 MT213215 6/30/2010 MT213219 6/30/2010 MT213228 7/31/2010 MT213244 7/31/2010 MT213250 7/31/2010 MT213256 7/31/2010 MT213259 7/31/2010 MT213264 7/31/2010 MT213271 7/31/2010 MT213275 7/31/2010 MT213278 7/31/2010 MT213281 7/31/2010 MT213287 7/31/2010 MT213290 7/31/2010 MT213299 7/31/2010 MT213302 7/31/2010 MT213308 7/31/2010 MT213329 7/31/2010 MT213346 7/31/2010 MT213354 8/31/2010 MT213357 8/31/2010 MT213360 8/31/2010 MT213365 8/31/2010 MT213368 8/31/2010 MT213375 8/31/2010 MT213380 8/31/2010 MT213386 8/31/2010 MT213391 8/30/2010 MT213394 8/31/2010 MT213398 8/31/2010 MT213404 8/31/2010 MT213412 8/31/2010 MT213419 8/31/2010 MT213425 8/31/2010 MT213432 8/31/2010 MT213441 9/11/2010 MT213446 9/11/2010 MT213451 9/11/2010 MT213456 9/30/2010 MT213464 9/30/2010 MT213477 9/30/2010 MT213481 9/30/2010; b) lot numbers: MT212406 10/1/2009 MT212561 12/1/2009 MT212697 1/31/2010 MT212750 2/1/2010 MT212811 2/1/2010 MT212868 3/1/2010 MT212948 3/1/2010 MT213035 4/30/2010 MT213106 5/31/2010 MT213151 6/30/2010 MT213212 6/30/2010 MT213343 7/31/2010 MT213371 8/31/2010
RECALLING FIRM/MANUFACTURER
Ethicon, Inc., Somerville, NJ,
REASON
There is the potential for the duckbill seal to become dislodged.
VOLUME OF PRODUCT IN COMMERCE
64, 707 total units
DISTRIBUTION Nationwide, United Arab Emirates, Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, China, Czech Republic, Germany, Denmark, Egypt, Spain, Finland, France, United Kingdom, Greece, Israel, Italy, Jordan, Republic of Korea, Mexico, Malaysia, Netherlands, Norway, New Zealand, Puerto Rico, Reunion, Russian Federation, Sweden, Slovenia, Turkey, Saudi Arabia, Venezuela and S. Africa

PRODUCT Syngo Imaging XS VA60 and VA70 in combination with a NAS or HSM license. a) Model number 7502029, b) Model number 10496279.
CODE a) Serial number 14086; b) serial number 1418
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA,
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany.
REASON
Incomplete amount of image data; specifically, the image count in the series table of the online and archive database will display the full amount of images received at the Syngo Imaging XS as archived. However, the zip file on the NAS or HSM will contain fewer images-those which have been archived until the time of the error/interruption.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION NY, OH

PRODUCT Boston Scientific 1.0mm x 570 mm rigid pneumatic probe for use only with Swiss LithoClast Select System model no. 840-300K, Swiss LithoClast Ultra System model no. 840-700K, or Swiss LithoClast Ultra Upgraded System model no. 840-701U, compatible with 330mm Ultrasound Probes (REF 840-714 and 840-715), Rx, sterile, no detectable latex; REF/catalog no 840-733.
CODE Lot #’s 12723202, 12745667, 12767883, 12777930, 12782625, 12808559, 12813607, 12850772 and 12861508
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Spencer, IN,
Manufacturer: EMS SA, Nylon, Switzerland.
REASON
The label incorrectly reads "compatible with 330mm ultrasound probes (Ref 840-714 and 840-715)" instead of bearing the correct statement "compatible with 403mm ultrasound probes (Ref 840-716 and 840-7170)."
VOLUME OF PRODUCT IN COMMERCE
173 units
DISTRIBUTION Nationwide

PRODUCT Respironics V60 Ventilator.
CODE
Domestic Serial Numbers: 100004544 100002914 100004984 100003149 100003670 100003864 100003903 100004026 100005240 100003673 100004994 100003919 100004548 201000133 201000298 201000096 100004553 100003051 100004125 201000131 100004625 201000315 201000132 100004622 100003689 201000049 100004543 100004025 100003692 100004122 201000496 100004133 100003663 100003002 100003044 100003045 100003047 100003087 100004550 100004987 100005111 100005113 100003050 100003089 100003748 100003863 100003902 100003907 100003908 100004016 100004017 100004018 100004019 100004020 100004021 100004022 100004023 100004024 100004034 100004080 100004082 100005101 201000497 201000042 100004323 201000129 100004549 100005105 100005112 100005152 100005114 100005143 100005248 100005327 201000097 100004325 100004123 201000044 100004558 100002913 201000053 201000047 100004620 100003088 100005145 100005157 100005238 100005243 100005245 100005249 100005250 100005254 100005333 100005335 100005330 100005486 201000334 100004554 100003862 201000587 100004081 100003684 100003691 100003046 201000130 100004555 100002915 100003006 100003000 100003040 201000342 201000099 100004623 100005395 100003665 100003747 100003760 100003737 100003662 100003753 100004541 100005331 100005497 100005500 100002910 201000313 100004985 100005388 100003082 201000197 201000135 100004624 201000200 201000043 100004621 100003916 201000134 100004557 100003658 100003758 201000048 100004556 100004627 201000491 201000054 100004322 100004077 100003910 100004121 201000495 100003052 100005117 100004124 100005116 100005253 100005336 100004028 100004030 100004076 100003661 100003667 100003756 100004027 100004083 100004126 100004128 201000343 201000494 100004983 201000128 100004320 100002908 100004982 100003081 100004995 100003906 100004075 201000490 201000492 201000493 201000498 201000499 201000582 201000583 201000584 100003911 100003912 100004078 201000585 201000586 201000588 201000589 201000590 201000591 201000592 100002909 100002912 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RECALLING FIRM/MANUFACTURER
Respironics California, Inc., Carlsbad, CA,
REASON
The recall was initiated to correct an issue with a component on the V60 Ventilator Power Management (PM) Printed Circuit Board (PCB). A component on the PCB has the potential to break off or become damaged if the PCB is removed from the ventilator. If this occurs, the ventilator may not properly switch between back up battery power and AC power. This can result in power loss during ventilation followed by the annunciation of the back up alarm and the display of a red Alarm LED during the following conditions: (1) During transport with the optional back up battery, (2) If there is an interruption of power caused by mains power loss, (3) Inadvertent disconnection of the power cord.
VOLUME OF PRODUCT IN COMMERCE
524 units
DISTRIBUTION Nationwide, Libya, Hong Kong, France, Italy, India, Spain, United Kingdom, Germany, Netherlands and Saudi Arabia

PRODUCT System 1000 family of Hemodialysis Instruments, including the System 1000, TINA, AURORA and AltraTouch; The Hemodialysis and Continuous Renal Replacement Therapy devices are used for acute and chronic hemodialysis, including high flux hemodialysis. The device is intended for use by trained operators when prescribed by a physician. The device is intended to be used with hollow fiber or parallel plate dialyzers.
CODE All systems with 4.B.09, 4.B.1.1 and 4.B.1.3 software
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGaw Park, IL,
Manufacturer: Baxter Healthcare Corp., Largo, FL.
REASON
When the main power is lost temporarily, a software anomaly prevents the instrument from automatically changing the ultra filtration rate (UFR) to the minimum value as described in the Operator's manual.
VOLUME OF PRODUCT IN COMMERCE
8,258 units
DISTRIBUTION Nationwide (including Puerto Rico and the Virgin Islands), Algeria, Argentina, Austria, Bahrain, Bangladesh, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, India, Indonesia, Ireland, Italy, Jordan, Korea, Latvia, Lebanon, Lithuania, Malaysia, Mauritania, Mexico, Morocco, Nigeria, Oman, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, Saipan, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Trinidad, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay and Venezuela

PRODUCT Guidant LATITUDE Communicator, model 6481. The LATITUDE Patient Management system enables physicians to periodically monitor both patient and device status remotely. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database.
CODE
Serial numbers: 029251, 064452, 059718, 064001, 056441, 059851, 070188, 072291, 312706, 305339, 312762, 004610, 024762, 049668, 061205, 067781, 051788, 056069, 068447, 069808, 008653, 068085, 057090, 023576, 028974, 017638, 603254, 064457, 069473, 069902, 071065, 072021, 073621, 073837, 312707, 605519, 603234, 603788, 072396, 059662, 056346, 301645, 312781, 307327, 067067, 055853, 060274, 605304, 305344, 302301, 605981, 009271, 056500, 300895, 602642, 030830, 301117, 055001, 049660, 047455, 056923, 309556, 044034, 063667, 005931, 067765, 063012, 050130, 051267, 055558, 060325, 060973, 063034, 306808, 306852, 309355, 041156, 062922, 063064, 061177, 300499, 039398, 039401, 039403, 060619, 065476, 058913, 056802, 073812 024833, 073560, 606104, 606288, 606604, 606826, 607180 608231 and 607180
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN,
Manufacturer: Benchmark Electronics Inc., Winona, MN.
REASON
The LATITUDE communicator (Model 6481) for a patient may not have been able to receive measurements from their weight scale or blood pressure monitor after initial setup. The issue has been resolved. If any patient weight or blood pressure readings are stored in the patient's sensor, they will be uploaded to LATITUDE after the patient's communicator calls in to Boston Scientifics servers. It may take up to 8 days for readings from the weight scale or blood pressure sensors to appear in LATITUDE. Physicians should note the timestamps on the sensor readings or weight alerts before basing any patient management decisions on this information.
VOLUME OF PRODUCT IN COMMERCE
100 units
DISTRIBUTION Nationwide

PRODUCT Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
CODE Lot #’s: 08311017 and 08336027
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI,
Manufacturer: Orchid Unique, Bridgeport, MI. and Stryker Ireland, Ltd. - Instruments Division, Carrigtwohill, County Cork, Ireland.
REASON
The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
VOLUME OF PRODUCT IN COMMERCE
93 boxes
DISTRIBUTION CA, GA, LA, OH, WI and Brazil