JUNE 2008
WEEK ENDING JUNE 7
PRODUCT MultiDiagnost Eleva Flat Detector X-Ray System; Part Number: SW
9896 001 43361, R
CODE Sysco Software
Version 2, release 4.1.1
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Philips Medical Systems North
America Co. Phillips, Bothell, WA,
Manufacturer: Philips Medical Systems
Nederlands, Best, Netherlands.
REASON Delay in
Imaging: MultiDiagnost Eleva with Flat Detector x-ray system cannot perform
fluoroscopy procedures while certain image file housekeeping operations are
performed. Fluoroscopy cannot be performed and new exposures are not able to be
acquired until the housekeeping operations are complete which may take several
minutes. The loss of system availability could occur during an interventional
procedure if the user conducts these housekeeping functions at that
time.
VOLUME OF PRODUCT IN COMMERCE 9
devices
DISTRIBUTION CO, MN, NC, NJ and TX
PRODUCT Ventana
Medical System's Symphony Staining System, KPA, Model #: 2200000, Catalog #:
900-SYM1 & 900-SYM3,
CODE
Serial
Numbers: 910006-910011, 910013-910016, 910019, 910020, 910022, 910023, 910029,
910031-910033, 910036, 910049, 910053, 910054, 910056, 910057, and
910060
RECALLING FIRM/MANUFACTURER Ventana Medical
Systems, Tucson, AZ,
REASON Shock hazard: Devices released prior to
full testing; the configuration of the Symphony instrument during Hi pot testing
procedures did not completely evaluate all components in the test loop. In
specific circumstances, a shock hazard exists.
VOLUME OF PRODUCT IN
COMMERCE 45 units
DISTRIBUTION Nationwide,
Japan and France
PRODUCT Selenia Full Field Digital Mammography System with Software v.
3.3.1.1; Full field digital, system, x-ray, mammographic; Model Number:
SEL-00002,
CODE
Serial Numbers:
28401060607, 28401060617, 28401060619, 28401060641, 28401060645, 28401071345,
28401071361, 28401071363, 28401082760, 28402050317, 28402071431, 28403060709,
28403071548, 28403071601, 28404060755, 28405060792, 28405060813, 28405071807,
28405071813, 28406071833, 28407050431, 28407060899, 28407071951, 28407072014,
28408050465, 28408072100, 28408072106, 28408072130, 28409030075, 28409030076,
28409050497, 28410072360, 28411061182, 28411061271, 28411072479, 28412050577,
28412050589, 28412061309, 28412061319, 28412061333, 28412061336, 28412061339,
28412072602, 29408072073, 28407072007S, 28409030072RF and
28409030077RM
RECALLING FIRM/MANUFACTURER Lorad, A Hologic, Inc., Danbury, CT,
REASON
Marker Misalignment: The new software
version contained a magnification factor that shows CAD markers misaligned with
the identified indications. The marked area is misaligned up to 2cm from the
indication.
VOLUME OF PRODUCT IN COMMERCE 73
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT EVMS (Enterprise Visual Medical System); Picture archiving and
communications system; Model Numbers: 5.30.4, 5.30.5, 5.30.6, 5.30.7, 5.40.0 and
7.0.0.1.,
CODE Model numbers
only
RECALLING FIRM/MANUFACTURER Emageon, Inc., Hartland,
WI,
REASON Miscalculation: The calculation of the
standard uptake value does not include the required calibration factor/decay
correction factor. The resulting value is incorrectly calculated, which may lead
to incorrect interpretation of tissue density. The calculation error exists in
both the software and user guide.
VOLUME OF PRODUCT IN
COMMERCE 99 units
DISTRIBUTION Nationwide
WEEK ENDING JUNE 14
PRODUCT ADVIA
Centaur Tnl-Ultra Assay, Troponin Immunoassay, 500 tests - Part/Catalog #
02790309, and 100 tests - Part/Catalog # 02789602. For in vitro diagnostic use, CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions
Diagnostics, Tarrytown, NY,
Manufacturer: Siemens Medical Solutions Diagnostics, East Walpole,
MA.
REASON Incorrect results: Falsely elevated
Troponin values have been reported which are inconsistent with the patient's
clinical picture and test negative by other Troponin assays.
VOLUME
OF PRODUCT IN COMMERCE 58,818
kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT GE Healthcare Proteus
XR/a Radiographic System, Model Number
2259976; previously marketed as the Silhouette FC,
CODE
00000010838HL1, 00000011061HL9,
00000011067HL6, 00000011185HL6, 00000012500HL5, 00000012667HL2, 00000013129HL2,
00000013372HL8, 00000013385HL0, 00000013543HL4, 00000013557HL4, 00000013800HL8,
00000014099HL6, 00000014104HL4, 00000014319HL8, 00000014327HL1, 00000014667HL0,
00000014677HL9, 00000015076HL3, 00000015383HL3, 00000015386HL6, 00000015400HL5,
00000015738HL8, 00000015744HL6, 00000015745HL3, 00000015750HL3, 00000015760HL2,
00000016174HL5, 00000016383HL2, 00000016386HL5, 00000016696HL7, 00000016707HL2,
00000016708HL0, 00000016709HL8, 00000016930HL0, 00000016954HL0, 00000016955HL7,
00000017119HL9, 00000017130HL6, 00000017131HL4, 00000017476HL3, 00000017477HL1,
00000017478HL9, 00000017480HL5, 00000017490HL4, 00000017492HL0, 00000017493HL8,
00000017599HL2, 00000017604HL0, 00000017608HL1, 00000017610HL7, 00000017613HL1,
00000017616HL4, 00000017788HL1, 00000017801HL2, 00000018476HL2, 00000018479HL6,
00000018483HL8, 00000019041HL3, 00000019048HL8, 00000019095HL9, 00000019098HL3,
00000019104HL9, 00000019110HL6, 00000019241HL9, 00000019244HL3, 00000019413HL4,
00000019419HL1, 00000019489HL4, 00000019496HL9, 00000019499HL3, 00000019501HL6,
00000019502HL4, 00000019669HL1, 00000019801HL0, 00000019886HL1, 00000019894HL5,
00000019959HL6, 00000020091HL5, 00000020092HL3, 00000020239HL0, 00000020243HL2,
00000020374HL5, 00000020967HL6, 00000021064HL1, 00000021197HL9, 00000021201HL9,
00000021204HL3, 00000021343HL9, 00000021344HL7, 00000021349HL6, 00000021552HL5,
00000021911HL3, 00000021921HL2, 00000021938HL6, 00000021953HL5, 00000022033HL5,
00000022333HL9, 00000022337HL0, 00000022412HL1, 00000022477HL4, 00000022600HL1,
00000022795HL9, 00000022931HL0, 00000023116HL7, 00000023122HL5, 00000023126HL6,
00000023412HL0, 00000023415HL3, 00000024386HL5, 00000024483HL0, 00000024588HL6,
00000024939HL1, 00000024940HL9, 00000025426HL8, 00000025475HL5, 00000025476HL3,
00000025477HL1, 00000025572HL9, 00000027104HL9, 00000027867HL1, 00000028057HL8,
00000028453HL9, 00000028524HL7, 00000028845HL6, 00000029098HL1, 00000029145HL0,
00000029502HL2, 00000029550HL1, 00000029634HL3, 00000029640HL0, 00000029969HL3,
00000030108HL5, 00000030113HL5, 00000030229HL9, 00000030232HL3, 00000030236HL4,
00000030633HL2, 00000030848HL6, 00000030920HL3, 00000030921HL1, 00000030976HL5,
00000031172HL0, 00000031175HL3, 00000031565HL5, 00000031702HL4, 00000031811HL3,
00000031928HL5, 00000031929HL3, 00000031930HL1, 00000032309HL7, 00000032311HL3,
00000032317HL0, 00000032319HL6, 00000032322HL0, 00000032850HL0, 00000032912HL8,
00000032916HL9, 00000032919HL3, 00000032920HL1, 00000033330HL2, 00000033388HL0,
00000033391HL4, 00000033408HL6, 00000033437HL5, 00000033509HL1, 00000033679HL2,
00000033681HL8, 00000033682HL6, 00000033727HL9, 00000033731HL1, 00000033884HL8,
00000033970HL5, 00000033971HL3, 00000033983HL8, 00000033984HL6, 00000034218HL8,
00000034420HL0, 00000034469HL7, 00000034470HL5, 00000034520HL7, 00000034644HL5,
00000034694HL0, 00000034762HL5, 00000034764HL1, 00000034913HL4, 00000034938HL1,
00000035052HL0, 00000035101HL5, 00000035159HL3, 00000035191HL6, 00000035244HL3,
00000035246HL8, 00000035247HL6, 00000035329HL2, 00000035445HL6, 00000035544HL6,
00000035547HL9, 00000035632HL9, 00000035641HL0, 00000036038HL8, 00000036068HL5,
00000036071HL9, 00000036100HL6, 00000036126HL1, 00000036128HL7, 00000036265HL7,
00000036362HL2, 00000036363HL0, 00000036431HL5, 00000036624HL5, 00000036625HL2,
00000036674HL0, 00000036698HL9, 00000036702HL9, 00000036882HL9, 00000036983HL5,
00000037104HL7, 00000037123HL7, 00000037351HL4, 00000037352HL2, 00000037353HL0,
00000037396HL9, 00000037596HL4, 00000037919HL8, 00000038423HL0, 00000038771HL2,
00000038772HL0, 00000039125HL0, 00000039581HL4, 00000039612HL7, 00000040366HL7,
00000040493HL9, 00000040728HL8, 00000040865HL8, 00000041290HL8, 00000041291HL6,
00000041511HL7, 00000041768HL3, 00000042367HL3, 00000042649HL4, 00000042650HL2,
00000042651HL0, 00000042701HL3, 00000042880HL5, 00000043029HL8, 00000043184HL1,
00000043265HL8, 00000043665HL9, 00000043727HL7, 00000043747HL5, 00000043751HL7,
00000044548HL6, 00000045475HL1, 00000045651HL7, 00000015925HL1, 00000019969HL5,
00000024476HL4, 00000027957HL0, 00000030025HL1, 00000030028HL5, 00000032711HL4,
00000035548HL7, 00000036428HL1, 00000036883HL7, 00000020371HL1, 00000021582HL2,
00000031922HL8, 00000033316HL1, 00000042706HL2, 00000020735HL7, 00000022513HL6,
00000022926HL0, 00000024376HL6, 00000031909HL5, 00000040521HL7, 00000041017HL5,
00000011544HL4, 00000014336HL2, 00000016171HL1, 00000016545HL6, 00000017123HL1,
00000017483HL9, 00000023189HL4, 00000028833HL2, 00000030875HL9, 00000030924HL5,
00000031916HL0, 00000031918HL6, 00000032909HL4, 00000033730HL3, 00000033974HL7,
00000034268HL3, 00000036165HL9, 00000042001HL8, 00000016177HL8, 00000031554HL9,
00000036626HL0, 00000013383HL5, 00000014323HL0, 00000019485HL2, 00000020232HL5,
00000010836HL5, 00000019679HL0, 00000023546HL5, 00000023547HL3, 00000030926HL0,
00000041996HL0, 00000042388HL9, 00000042537HL1, 00000011063HL5, 00000015391HL6,
00000017138HL9, 00000021058HL3, 00000030918HL7, 00000040086HL1, 00000010328HL3,
00000013375HL1, 00000014335HL4, 00000015065HL6, 00000015081HL3, 00000015747HL9,
00000016371HL7, 00000016701HL5, 00000017125HL6, 00000017481HL3, 00000019482HL9,
00000019486HL0, 00000019678HL2, 00000019680HL8, 00000019788HL9, 00000020081HL6,
00000020224HL2, 00000021639HL0, 00000022032HL7, 00000023118HL3, 00000023181HL1,
00000024432HL7, 00000029259HL9, 00000031908HL7, 00000031914HL5, 00000032231HL3,
00000032897HL1, 00000033724HL6, 00000033725HL3, 00000033968HL9, 00000034260HL0,
00000034459HL8, 00000034462HL2, 00000034783HL1, 00000035377HL1, 00000035378HL9,
00000036563HL5, 00000037254HL0, 00000038190HL5, 00000016175HL2, 00000019042HL1,
00000013796HL8, 00000011182HL3, 00000032313HL9, 00000012475HL0, 00000020222HL6,
00000029743HL2, 00000033726HL1, 00000020732HL4, 00000020737HL3, 00000012674HL8,
00000021551HL7, 00000031689HL3, 00000010651HL8, 00000015757HL8, 00000022520HL1,
00000015082HL1, 00000015153HL0, 00000021644HL0, 00000013373HL6, 00000015158HL9,
00000022606HL8, 00000022607HL6, 00000024489HL2, 00000024590HL2, 00000024671HL0,
00000024689HL2, 00000030446HL9, 00000030460HL0, 00000030927HL8, 00000036429HL9,
00000015387HL4, 00000039893HL3, 00000039895HL8, 00000039962HL6, 00000040002HL8,
00000040072HL1, 00000040164HL6, 00000040167HL9, 00000022402HL2, 00000036266HL5,
00000036914HL0, 00000037252HL4, 00000013564HL0
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: GE Hangwei Medical Systems Co LTD, Beijing Econ &
Tech Dev Zone, China.
REASON The warning label that is required by 21
CFR 1020.30(j) was not on the control console of the Proteus XR/a Radiographic
X-ray System, Model 2259976.
VOLUME OF PRODUCT IN
COMMERCE 400 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a)
Pathway Balloon Expandable Ureteral Access Sheath- 11/14/28, Ureteral dilator, Catalog Number: 255100; Product Number: M0062551000,
Onset Medical,
b) Pathway
Balloon Expandable Ureteral Access Sheath- 11/14/36, Ureteral dilator, Catalog Number: 255101; Product Number: M0062551010,
c) Pathway Balloon Expandable Ureteral Access Sheath-
11/14/46, Ureteral dilator, Catalog Number: 255102;
Product Number: M0062551020,
d) Pathway Balloon
Expandable Ureteral Access Sheath- 13/16/28, Ureteral dilator, Catalog Number: 255103; Product Number: M0062551030,
e) Pathway Balloon Expandable Ureteral Access Sheath-
13/16/36, Ureteral dilator, Catalog Number: 255104;
Product Number: M0062551040, f) Pathway Balloon
Expandable Ureteral Access Sheath- 13/16/46, Ureteral dilator,
Catalog Number: 255105; Product Number: M0062551050,
g) Pathway Balloon Expandable Ureteral Access Sheath-
12/15/28, Ureteral dilator, Catalog Number: 255106;
Product Number: M0062551060,
h) Pathway Balloon
Expandable Ureteral Access Sheath- 12/15/36, Ureteral dilator, Catalog Number: 255107; Product Number: M0062551070,
i) Pathway Balloon Expandable Ureteral Access Sheath-
12/15/46, Ureteral dilator, Catalog Number: 255108; Product
Number: M0062551080,
CODE
a) Lot
numbers: W03-1606, W03-1649, W03-1700, W03-1702, W03-1924, W03-2077, W03-2143, W03-2277, W03-2283;
b) Lot
numbers: W03-1527, W03-1579, W03-1587, W03-1595, W03-1623, W03-1644, W03-1753, W03-1786, W03-1787, W03-1813, W03-1832,
W03-1938, W03-2108,
W03-2110, W03-2139, W03-2271,
W03-2278, W03-2279, W03-2280, W03-2535, W03-2589;
c)
Lot numbers: W03-1613, W03-1747, W03-1805, W03-1945, W03-2111, W03-2272, W03-2484, W03-2577;
d) Lot numbers: W03-1473,
W03-1474, W03-1909, W03-2055, W03-2112, W03-2144,
W03-2232, W03-2284, W03-2232, W03-2391, W03-2464, W03-2579;
e) Lot numbers:
W03-1482, W03-1491, W03-1508, W03-1524, W03-1740, W03-1917, W03-2107, W03-2113, W03-2214, W03-2216, W03-2236,
W03-2239, W03-2240,
W03-2285, W03-2354, W03-2410,
W03-2446, W03-2457, W03-2483, W03-2580;
f) Lot numbers: W03-1464, W03-1767,
W03-2106, W03-2215, W03-2241, W03-2242, W03-2275,
W03-2470, W03-2566;
g) Lot numbers: W03-2337, W03-2359, W03-2392, W03-2553,
W03-2554, W03-2590;
h) Lot numbers: W03-2339, W03-2342, W03-2362, W03-2382,
W03-2409, W03-2431, W03-2434, W03-2436, W03-2439,
W03-2479, W03-2482, W03-2550, W03-2555,
W03-2581,
W03-2591;
i) Lot Number: W03-2341, W03-2357, W03-2395,
W03-2578
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Boston Scientific Corporation, Natick, MA,
Manufacturer: Onset Medical Corporation, Irvin, CA.
REASON
Sheath Removal Difficulty:
Users experience difficulty in removing the sheath.
VOLUME OF PRODUCT
IN COMMERCE 1,998
units
DISTRIBUTION Nationwide
PRODUCT
AMO VISX STAR Excimer Laser System 0030-4864 Chair component of the
System 0030-2381. Each chair also has a serial number, which is the same as the
serial number assigned to the system it is part of,
CODE
Serial Numbers: 2129 2146 2181 2197 3028
3030 3031 3036 3480 3624 5346 5635 3751 3863 5345 5088 3113 5065 3938 2158 2177
2204 2205 3254 3387 3397 3754 3937 5030 5122 3023 3194 3435 3456 3732 3830 5027
5283 5313 5334 5382 5456 5566 5606 5643 3037 3122 3130 3233 3246 3874 5006 5021
5032 5125 5224 5415 5671 3574 5306 5695 3816 2200 3029 3284 3293 3528 3536 3697
3712 3731 3802 3840 3927 5012 5014 5034 5064 5079 5151 5153 5154 5175 5231 5267
5287 5307 5317 5410 5559 5573 5656 5720 5779 3884 5649 3314 3974 5495 3241 and
5127
RECALLING FIRM/MANUFACTURER VISX Incorporated, a
Subsidiary of AMO Inc., Santa Clara, CA,
REASON Firm
received two complaints (including one injury complaint) associated with the
movement of the VISX chair while in the patient loading ("fully swung out"
unlocked) position under an IntraLase FS laser.
VOLUME OF PRODUCT IN
COMMERCE 1,853 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
B-K Medical Intraoperative Transducer Type 8814, diagnostic
ultrasound transducer,
CODE Serial
Numbers: 1864742, 1869148, 1869619, 1870824, 1870825, 1872061, and
1875317.
RECALLING FIRM/MANUFACTURER
Recalling Firm: B
& K Medical Systems, Inc., Wilmington, MA,
Manufacturer: B-K Medical A/S,
Herlev, Denmark.
REASON Crack: Incomplete glue joint in the
device housing may affect electrical safety or sterilization.
VOLUME
OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION MA, MI, PA, TX, and OR
PRODUCT
a) CalMed
Pericardial Sump, with 1/8"/0.3175 cm Connector Single Use Only. Do Not Reuse. Catalog Number REF SU-20601;
b) CalMed Pericardial Sump, with 1/4"/0.635 cm Connector, Single
Use Only. Do Not Reuse; Catalog Number REF SU-20602;
c) CalMed Malleable Pericardial Sump, Single Use Only.
Do Not Reuse. Catalog Number REF SU-20802;
CODE
a) Lot Number S03482;
b) Lot
Numbers: S040846 S040754 S040914 S041006 S041122 S050061NS S050232 S050233 S050329 S050335NS S050416NS S050538NS S050741
S050759NS
S050766NS S050858 S050923NS S050943NS S051041
S051130 S051151 S051175 S051275NS S051318NS S051356NS
S051402NS S051490 S051511 S051560NS S051582NS S051596NS
S051677ES S051844NS S051881 S051906ES S051925 S052007NS
S052142NS S052193NS S052295 S052338NS S060045 S060092NS
S060202 S060285 S060401NS S060402NS S060454NS;
Lot No.
S060492NS S060683NS S060965NS S061010NS S061226 S061434
S061441NS S061513NS S061695NS S061760NS S061838NS S061916 S062015NS
S062055NS S062132 S070135NS S070252NS S070324 S070482NS
S070501NS S070633 S070820NS S070870NS S070882 S070998
S071002NS S071456NS S071457NS S071458 S071459NS S071460NS
S071534 S071606 S071607 S071688 S071731NS S071766 S071989
S072100NS S072121NS, and S072133NS;
c) Lot Numbers: S040870 S041515 S050537
S050907 S050919 S051982 S052118 S052325 S060056 S060158
S060909 S060924 S070307 S071047 S071462NS
S071463 S071620
S071754 and S071985
RECALLING
FIRM/MANUFACTURER California Medical Laboratories, Inc., Costa Mesa,
CA,
REASON Fragment of material: The product may
have a loose, stainless steel stringer flash located at the distal tip of the
product.
VOLUME OF PRODUCT IN COMMERCE 31,124
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Presource Standard Sterile OR Scissors; straight scissors, S/B,
5.5", made in Pakistan; individually packaged in rigid styrene roll stock with a
tyvek top, 50 units per case; Catalog #SSI-0003;
CODE Mfg Date 10/15/07, Order no.
247610
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cardinal Health, McGaw Park, IL,
Manufacturer: Convertors De Mexico,
S.A. De C.V., Ciudad, Juarez,
Mexico.
REASON The
product has the potential of being non-sterile.
VOLUME OF PRODUCT IN
COMMERCE 16 cases
DISTRIBUTION KS,
MO
PRODUCT
a) U19
Socketed Integrated Circuit ("U19 IC") on the logic board of Alaris Pump modules
(aka. Medley Pump modules), Model 8100 built on
or before September 8, 2005.
b)
Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26, 2004: (1) Alaris PC
point-of-care unit ("PC Unit") (Model 8000)* (a.k.a.
Medley PC Unit), (2) Alaris Pump Module (Model 8100)
(a.k.a. Medley Pump Module), (3) Alaris Syringe Module (Model 8110)
(a.k.a. Medley Syringe Module), (4) Alaris PCA Module
(Model 8120) (a.k.a. Medley PCA Module), (5) Alaris SpO2
Module (Models 8210) (a.k.a. Medley SpO2 Module) with
Nellcor technology, and (6) Alaris SpO2 Module (Models
8220) (a.k.a. Medley SpO2 Module) with Masimo technology,
c) U9 Socket Integrated Circuit ("U9 IC") on the
display board of the following Alaris System modules
built on or before October 4, 2005: (1) Alaris Syringe
module (Model 8110) (a.k.a. Medley Syringe module) (2) Alaris PCA module (Model 8120) (a.k.a. Medley PCA module),
CODE
The firm’s website has a list of the
serial numbers for the affected devices: http://www.cardinal.com/alarisnotice/
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal
Health 303 Inc., dba Alaris Products, San Diego, CA,
Manufacturer: Cardinal Health 303 dba Cardinal Health, San Diego, CA.
REASON
a) A channel
error on an affected Alaris System module will stop an active infusion (or monitoring) with an audible and visual alarm. Channel
errors due to failures of the U19 Socketed Integrated
Circuits (U19 IC) on the logic board of the Alaris Pump
module ("Pump module"). The user will be required
to replace the affected module.
b) A channel error on an affected Alaris
System module will stop an active infusion (or
monitoring) with an audible and visual alarm. Channel errors with the Alaris System due to the Inter-Unit Interface
(IUI) connectors
on all Alaris System modules
(manufactured on or before
March 26, 2004). Grey Inter-Unit Interface Connectors ("IUI") on the following Alaris System modules built on or before March 26,
2004:
(1) Alaris PC point-of-care unit ("PC Unit") (Model
8000)* (a.k.a. Medley PC Unit),
(2) Alaris Pump Module
(Model 8100) (a.k.a. Medley Pump Module),
(3) Alaris
Syringe Module (Model 8110) (a.k.a. Medley Syringe Module),
(4) Alaris PCA Module (Model 8120) (a.k.a. Medley PCA
Module),
(5) Alaris SpO2 Module (Models 8210) (a.k.a.
Medley SpO2 Module) with Nellcor technology, and
(6) Alaris SpO2 Module (Models 8220) (a.k.a. Medley SpO2
Module) with Masimo technology. The user will be required
to replace the affected module.
c) A channel error on an affected Alaris
System module will stop an active infusion (or
monitoring) with an audible and visual alarm. Channel errors due to failure of
the U9 Socketed Integrated Circuits (U9 IC) on the
display board of the Alaris Syringe Module ("Syringe
module") and Alaris PCA module ("PCA module") for modules
manufactured on or before October 4, 2005. The user will be required to replace
the affected module.
VOLUME OF PRODUCT IN
COMMERCE
a) 85,286
b) 77,515
c)
8,286
DISTRIBUTION Nationwide and Internationally
WEEK ENDING JUNE 21
PRODUCT GE LOGIQ
3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2,
CODE
Serial numbers: 26022WS4,
26023WS2, 26346WS7, 2641WS8, 31001WS1, 34381WS4, 36460WS4, 36461WS2, 43734WS3,
43735WS0, 43736WS8, 43737WS6, 43994WS3, 43995WS0, 43998WS4, 44000WS8, 44001WS6,
44002WS4, 44003WS2, 44004WS0, 44005WS7, 44011WS5, 44012WS3, 44013WS1, 44015WS6,
44016WS4, 44018WS0, 44019WS8, 44020WS6, 44100WS6, 44153WS5, 44157WS6, 44159WS2,
44270WS7, 44273WS1, 44274WS9, 44275WS6, 44276WS4, 44277WS2, 44532WS0, 44533WS8,
44817WS5, 44819WS1, 44820WS9, 44821WS7, 44822WS5, 44825WS8, 44826WS6, 44908WS2,
44909WS0, 44912WS4, 44914WS0, 44915WS7, 44989WS2, 44990WS0, 44991WS8, 44992WS6,
44994WS2, 45088WS2, 45089WS0, 5122WS7
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare Clinical Systems,
Milwaukee, WI,
Manufacturer: Wipro GE
Medical Systems Ltd., Whitefield, Bangalore, India.
REASON
Inaccurate guidelines: The BE9C is an
optional, small radius Bi-planar convex probe intended for use with the LOGIQ 3
Expert system in Urology application. An attempt by the user to activate the
biopsy guidelines while this probe is in use will cause incorrect guidelines to
be displayed on the image. The incorrect guidelines are recognized by their
orientation that is left/right reversed from the usual guideline orientation.
Any attempt to use the inaccurate guidelines may result in a biopsy needle
puncture at the unintended location.
VOLUME OF PRODUCT IN
COMMERCE 61 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) BIOPLEX 2200 SYPHILIS IgG Kit: 100 tests - Catalog No. 665-1450. The product is a multiplex flow immunoassay intended for
the qualitative detection of Treponema pallidium IgG
antibodies in human serum,
b)
BIOPLEX 2200 EBV IgG KIT, CALIBRATORS, AND CONTROLS: 100
tests - Catalog No. 665-1250. The product is multiflow immunoassay intended for the quantitative detection of IgG antibodies
to three (3) seperate EBV antigens in human serum. They
are: 1) Epstein-Barr Virus Nuclear Antigen-1
(EBV-NA-1);
2) Viral Capsid Antigen (EBV VCA); and 3) Early Antigen diffuse (EBV EA-D),
c) BIOPLEX 2200 EBV
IgM KIT, CALIBRATORS, AND CONTROLS: 100 tests – Catalog
No. 665-1350. The product is a multiplex flow immunoassay intended for the qualitative detection of two (2)
analytes;
Epstein-Barr Virus Viral Capsid
Antigen (EBV VCA) IgM
antibodies and Heterophile antibodies in human serum,
d) BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM: a) 100
test – Catalog No. 665-1150; and b) the 5,000 tests -
Catalog No. 665-1155. The product is used as an aid
in the diagnosis of systemic autoimmune diseases,
CODE
a) Lot Numbers: 946314 Exp. 10/31/07,
950630 Exp. 1/31/08 and 946899 Exp. 2/28/08;
b) Lot
Numbers: 943710 Exp. 7/30/07 and 943711 Exp. 4/30/08;
c) Lot Numbers: 943712
Exp. 7/30/07 and 943713 Exp. 4/30/08;
d) Eleven (11) Lots, as follows: Lot
Numbers: 931396 Exp. 9/30/06; 935424 Exp. 3/31/07; 941886
Exp. 3/31/07; 935682 Exp. 4/30/07; 937351 Exp. 6/30/07;
941343 Exp. 3/31/08; 941428 Exp. 4/30/08; 945246 Exp. 9/30/08;
945875 Exp. 12/31/08; 945248 Exp. 10/31/08 and 945875
Exp. 12/31/08
RECALLING FIRM/MANUFACTURER Bio-Rad
Laboratories, Redmond, WA,
REASON False negative
results due to reagent packs exhibiting low signal.
VOLUME OF PRODUCT
IN COMMERCE 796 Syphilis IgG Kits; 1,020 EBV IgG Kits; 996 EBV IgM
Kits; 1,390,400 ANA Screen with MDSS
Kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT da Vinci S Surgical System, Model number IS2000 Revision number A51
P5; endoscopic surgical control system, CODE System numbers SG015, SG020, SG040,
SG103, SG152, SG169, SG179, SG213, SG215, SG355, top level part numbers
380267-01, 380431-02, and 380431-05
RECALLING
FIRM/MANUFACTURER Intuitive Surgical, Inc., Sunnyvale, CA,
REASON
Delay in responding: In certain
circumstances, the device may not respond immediately to a user's command such
as master clutch or camera control.
VOLUME OF PRODUCT IN
COMMERCE 9 systems
DISTRIBUTION TX, NJ, WA, NV, HI, MI, NH and CA
PRODUCT
a) Trident Hemispherical Solid BK Acetabular Shells; 42mm to 74mm, Hydroxylapatite Coated;
Multiholed; Use with Size A
insert; hip prosthesis Component. Catalog number: 500-01-42A, 42 mm; 500-01-44B, 44 mm; 500-01-56C, 46mm;
500-01-48D, 48mm; 500-01-50D, 50mm; 500-01-52E, 52mm; 500-01-54D, 54mm; 500-01-56,
56mm; 500-01-58E, 58E; 500-01-60G, 60mm; 500-01-62G,
62mm; 500-01-64H, 64mm; 500-01-66H, 66mm; 500-01-68I,
68mm; 500-01-701, 70mm; 500-01-72J, 72mm; 500-01-74J, 74mm,
b) Trident Hemispherical Acetabular Shells HA Solid BK 42mm-
74mm; Arc Deposited; Hydroxylapatite Coated; Multiholed;
Use with Size A insert; hip prosthesis component, Stryker Orthopaedics; Catalog Number’s: 500-11-42A, 42mm;
500-11-44B, 44mm; 500-11-46C, 46mm; 500-11-48D, 48mm; 500-11-50D, 50mm; 500-11-52E, 52mm; 500-11-54E, 54mm; 500-11-56F, 56mm;
500-11-58-F, 58mm; 500-11-60G, 60mm; 500-11-62G, 62mm;
500-11-64H, 64mm; 500-11-66H, 66mm; 500-11-681, 68mm;
500-11-701, 70mm; 500-11-72J, 72mm; 500-11-74J, 74mm,
c) Trident Hemispherical Cluster; 42mm - 74 mm Arc
Deposited; Hydroxylapatite Coated; Multiholed; Use with
Size A insert; hip prosthesis component, Stryker Orthopaedics;
Catalog Numbers: # 502-01-42A; 42mm;
502-01-44B, 44mm; 502-01-46C, 46mm; 502-01-48D, 48mm;
502-01-50D, 50mm; 502-01-52E, 52mm; 502-01-54E, 54mm;
502-01-56F, 56mm; 502-01-58F, 58mm;, 502-01-60G, 60mm; 502-01-62G, 62mm; 502-01-64H, 64mm; 502-01-66H, 66mm; 502-01-681, 68mm;
502-01-701, 70mm;,
502-01-72J, 72mm; 502-01-74J, 74mm,
d) Trident Hemispherical HA Cluster, 42 mm - 74mm Arc
Deposited; Hydroxylapatite Coated; Multiholed; Use with
Size A insert; hip prosthesis component, Stryker Orthopaedics,
Catalog Numbers: 502-11-42A, 42mm;502-11-44b, 44mm;
502-11-46C, 46mm; 502-11-48D, 48mm; 502-11-50D, 50mm;
502-11-52E, 52mm; 502-11-54E, 54mm; 502-11-56F, 56mm;
502-11-58F, 58mm; 502-11-60G, 60mm; 502-11-62G, 62mm;
502-11-64H, 64mm; 502-11-66H, 66mm; 502-11-68I, 68mm; 502-11-70I, 70mm; 502-11-72J. 72mm; 502-11-74J, 74mm,
e) Trident Hemispherical Multi Arc Deposited; Hydroxylapatite
Coated; Multiholed; Use with Size A insert; hip
prosthesis component, Stryker Orthopaedics, Catalog
Numbers: 500-11-42A; 508-11-4B; 508-11-46C; 508-11-48D; 508-11-50D; 508-11-52E; 508-11-54E; 508-11-56F; 508-11-58F;
508-11-60G; 508-11-62G; 50811-64H; 508-11-66H;
508-11-68I; 508-11-70I; 598-11-72J; 508-11-74J,
f) Trident PSL Acetabular Shells;
Trident PSL HA Solid Back, 40 mm to 73 mm, hip prosthesis component, Stryker Orthopaedics, 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 2469501A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601E 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469901A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469902A 540-11-42B
TRIDENT PSL HA
SOLID BACK 42mm 3383301A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301C
540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3452801A 540-11-44C
TRIDENT PSL HA
SOLID BACK 44mm 2468301A 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301D
540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2485601A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102E
540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3452501A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D
TRIDENT PSL HA
SOLID BACK 48mm 3088702A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2483203A
540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E
TRIDENT PSL HA
SOLID BACK 50mm 2925906A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2518502A
540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E
TRIDENT PSL HA
SOLID BACK 52mm 2926107A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2518601A
540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F
TRIDENT PSL HA
SOLID BACK 54mm 2926003A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926008A
540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F
TRIDENT PSL HA
SOLID BACK 56mm 2518702A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518704A
540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F
TRIDENT PSL HA
SOLID BACK 56mm 3118502A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468901A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H
TRIDENT PSL HA SOLID BACK
62mm 3088802D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H
TRIDENT PSL HA
SOLID BACK 64mm 2483902F 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2503601A
540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 3712001A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2445101D 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101E
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2484501C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501E
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2551301A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2910902A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910903A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2990801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2445202A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2484701D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701E
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2517501A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501C
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2651001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001C
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2651001F 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2657801D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911001E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911002A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911003D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911005A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005D
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2551901D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2651101D 540-11-70J
T RIDENT PSL HA SOLID BACK 70mm 2911102A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2911102D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 5334001A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2503501A
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 2552201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201D
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 2651201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2911201A
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 3452901A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901D,
g) Trident PSL HA Cluster: 40 mm to 72 mm, hip
prosthesis component,540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 2469501A
540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3324601C 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3383201A 540-11-40A
TRIDENT PSL HA SOLID BACK 40mm 3452701A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1233601E
540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 1266301A 540-11-42B
TRIDENT PSL HA
SOLID BACK 42mm 2469901A 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 2469902A
540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3383301A 540-11-42B
TRIDENT PSL HA
SOLID BACK 42mm 3383301C 540-11-42B
TRIDENT PSL HA SOLID BACK 42mm 3452801A
540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2468301A 540-11-44C
TRIDENT PSL HA
SOLID BACK 44mm 2468301D 540-11-44C
TRIDENT PSL HA SOLID BACK 44mm 2485601A
540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2444801A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2468401A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2468401D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2517201A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2517201D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2549701A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919001A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919001D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919002A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919002D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919003A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919103A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919104A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 2919104D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104101A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102A 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102D 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104102E 540-11-46D
TRIDENT PSL HA SOLID BACK 46mm 3104103A 540-11-46D
TRIDENT PSL HA
SOLID BACK 46mm 3452501A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468501A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468502A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468503A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2468503D 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483101A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102C 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2483102D 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2863001A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2863002A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 2954001A 540-11-48D
TRIDENT PSL HA SOLID BACK 48mm 3088702A 540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2483203A
540-11-50E
TRIDENT PSL HA SOLID BACK 50mm 2825801A 540-11-50E
TRIDENT PSL HA
SOLID BACK 50mm 2925906A 540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2518502A
540-11-52E
TRIDENT PSL HA SOLID BACK 52mm 2713204A 540-11-52E
TRIDENT PSL HA
SOLID BACK 52mm 2926107A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2518601A
540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926001A 540-11-54F
TRIDENT PSL HA
SOLID BACK 54mm 2926003A 540-11-54F
TRIDENT PSL HA SOLID BACK 54mm 2926008A
540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2483301A 540-11-56F
TRIDENT PSL HA
SOLID BACK 56mm 2518702A 540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2518704A
540-11-56F
TRIDENT PSL HA SOLID BACK 56mm 2713502A 540-11-56F
TRIDENT PSL HA
SOLID BACK 56mm 3118502A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468901A
540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2468902A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2484905A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2518802A 540-11-58G
TRIDENT PSL HA SOLID BACK 58mm 2941802A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469001A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469002A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469002C 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469003A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2469003D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2483602A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2483602D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2517702A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2650601A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2826401C 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2826401D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941901A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941901D 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941902A 540-11-60G
TRIDENT PSL HA SOLID BACK 60mm 2941903A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483701D 540-11-62H
TRIDENT PSL HA
SOLID BACK 62mm 2483701E 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702A
540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2483702D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517601A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517602A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517602D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2517603A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2650701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2910701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949801A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802C 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2949802D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 2995701E
540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802A 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3088802D 540-11-62H
TRIDENT PSL HA SOLID BACK 62mm 3118802A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2445001A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2445001D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483901A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902C 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2483902E 540-11-64H
TRIDENT PSL HA
SOLID BACK 64mm 2483902F 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2503601A
540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2551101D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801C 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2650801D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2734501A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911301A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911302A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2911303A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2953801A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 2953801D 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 3233702A 540-11-64H
TRIDENT PSL HA SOLID BACK 64mm 3233704A 540-11-64H
TRIDENT PSL HA
SOLID BACK 64mm 3712001A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101C 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2445101D 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2445101E
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2484501C 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2484501E
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2517401A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2551301A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2650901C 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2910902A 540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910903A
540-11-66I
TRIDENT PSL HA SOLID BACK 66mm 2910904A 540-11-66I
TRIDENT PSL HA
SOLID BACK 66mm 2990801A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2445201D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2445202A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701C 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2484701D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484701E
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2484702A 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2517501A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501C
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2517501D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2651001A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001C
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2651001D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2651001F 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2657801C 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2657801D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911001D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911001E 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911002A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911003A 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911003D 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004A
540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911004D 540-11-68I
TRIDENT PSL HA
SOLID BACK 66mm 2911005A 540-11-68I
TRIDENT PSL HA SOLID BACK 66mm 2911005D
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2551901A 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2551901D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2651101C 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2651101D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 2911102C 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 2911102D 540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001A
540-11-70J
TRIDENT PSL HA SOLID BACK 70mm 3000001D 540-11-70J
TRIDENT PSL HA
SOLID BACK 70mm 5334001A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2503501A
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 2552201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2552201D
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2651201A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 2651201C 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 2911201A
540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3000101A 540-11-72J
TRIDENT PSL HA
SOLID BACK 72mm 3452901A 540-11-72J
TRIDENT PSL HA SOLID BACK 72mm 3452901D
CODE
All lot codes with
an expiration date between January 2005 (2005-01) and December 2012
(2012-12)
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Howmedica Osteonics Corp., Mahwah, NJ,
Manufacturer: Stryker Ireland, Ltd.,
Orthopaedics, Carrigtohill, County Cork, Ireland.
REASON
Foreign material: Some of the parts
tested exceeded Stryker Orthopaedics internal acceptance criteria for
manufacturing residuals.
VOLUME OF PRODUCT IN
COMMERCE 129,312 Trident Hemispherical; 10,191
PSL's
DISTRIBUTION Nationwide