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U.S. Department of Health and Human Services

Class 2 Device Recall ROTULE "913" D32

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 Class 2 Device Recall ROTULE "913" D32 see related information
Date Posted October 31, 2012
Recall Status1 Terminated on January 07, 2014
Recall Number Z-0184-2013
Recall Event ID 63338
510(K)Number K092201  K021346  K043073  K111698  K052915  K003016 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product Knee Components:
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380
INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876
INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952
INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345
INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335
INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535
PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238
PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596
PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903
PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241
TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967
TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599
TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733
TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734
TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344
TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876
TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877
CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839
CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301
INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533
INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536
INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531
INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542
INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540
INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017
PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556
PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563
PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260
PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557
PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559
TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577
TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738
TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582
TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587
PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017
PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824
PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727
2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520
PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212
PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000
PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226
PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273
PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228
PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258
PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572
PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845
PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846
PLATEAU TIBI
Code Information 5, PPB30164, Lot Numbers: V10278847 and W11386265
PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929
PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239
ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229
ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499
CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773
CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523
1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070
1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693
CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301
PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711
PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380
PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012
PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381
PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339

PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866
PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118
PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294
PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233
PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119
PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234
PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120
PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191
PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282
PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295
PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706
Recalling Firm/
Manufacturer
Wright Medical Technology Inc
5677 Airline Rd
Arlington TN 38002-9501
For Additional Information Contact Doug Shufelt
901-867-4655
Manufacturer Reason
for Recall
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
FDA Determined
Cause 2
Packaging process control
Action Wright sent an Urgent Product Recall Notification letter dated September 19, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for affected product and immediately return to Wright Medical Technology, Inc. Customers were asked to complete and return the enclosed notification form by fax to 901-867-7401. For questions customers should call 901-867-4324. For questions regarding this recall call 901-867-4655.
Quantity in Commerce 729 units
Distribution Worldwide Distribution - USA (nationwide) and Internationally to Canada, Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Italy, Latvia, Lithuania, Norway, Poland, Portugal, Serbia, Slovakia, Slovenia, Spain, The Netherlands, Argentina, Brazil, Chile, China, Japan, Taiwan, Turkey, United Arab Emirates, Australia, South Africa, Russia, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = WRIGHT MEDICAL TECHNOLOGY, INC.
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