Knee Components: ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "...
FDA Device Recall #Z-0184-2013 — Class II — September 5, 2012
Recall Summary
| Recall Number | Z-0184-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 5, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Wright Medical Technology Inc |
| Location | Arlington, TN |
| Product Type | Devices |
| Quantity | 729 units |
Product Description
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
Reason for Recall
There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.
Distribution Pattern
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.
Lot / Code Information
ROTULE "913" D=32 , Part Number PGA00030, Lot Number X02383380 INSERT TIBIAL "913 PCR" T.1 - EP.10-, PGA00050, Lot Numbers: V11272719, W02300988, W09372781, W09372781, and W10372876 INSERT TIBIAL "913 PCR" T.1 - EP.14-, PGA00054, Lot Number: V0266952 INSERT TIBIAL "913 PCR" T.2 - EP.10-, PGA00080, Lot Numbers: X02396582, X05401377, and W01287345 INSERT TIBIAL "913 PCR" T.3 - EP.10-, PGA00110, Lot Numbers: W09359102, X03396584, and W1166335 INSERT TIBIAL "913 PCR" T.5 - EP.14-, PGA00174, Lot Number: W0675535 PLATEAU TIBIAL "913" T.4 MOINS , PGA00216, Lot Number: X10391238 PLATEAU TIBIAL "913" T.5 MOINS , PGA00218, Lot Numbers: V0379902 and V0381596 PLATEAU TIBIAL "913" T.1 , PGA00230, Lot Numbers: W05327837 and W0779903 PLATEAU TIBIAL "913" T.2 PLUS , PGA00252, Lot Number: X06391241 TIGE INTRAMEDULLAIRE "913" D=16 L=75, PGA00716, Lot Number: X02382967 TIGE INTRAMEDULLAIRE "913" D=12 L=125, PGA00752, Lot Number: W06322599 TIGE INTRAMEDULLAIRE "913" D=14 L=125, PGA00754, Lot Number: V12272733 TIGE INTRAMEDULLAIRE "913" D=16 L=125, PGA00756, Lot Number: V12272734 TIGE INTRAMEDULLAIRE "913" D=18 L=125, PGA00758, Lot Number: W04336344 TIGE DE REPRISE FEMO/TIB. "913" D=14 L=75, PGA00814, Lot Number: V0767876 TIGE DE REPRISE FEMO/TIB. "913" D=16 L=75, PGA00816, Lot Number: V0767877 CALE TIBIALE "913" T.1 -EP.8- , PGA00950, Lot Number: W0380839 CALE TIBIALE "913" T.2 -EP.8- , PGA00952, Lot Number: V0773498 and V0973301 INSERT TIBIAL "913 RS" T.1 - EP.10-, PGA14010, Lot Number: V0782533 INSERT TIBIAL "913 RS" T.1 - EP.12-, PGA14012, Lot Number: V0766107 and V0782536 INSERT TIBIAL "913 RS" T.1 - EP.16-, PGA14016, V0782531 INSERT TIBIAL "913 RS" T.5 - EP.12-, PGA14044, Lot Number V0782542 INSERT TIBIAL "913 RS" T.5 - EP.14-, PGA14046, Lot Number: V0782540 INSERT TIBIAL "913 MP" T.1 GAUCHE -EP.17-, PGA14508, Lot Number: V05210017 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 38, PGA20016, Lot Numbers: X03397144, X04401212, X05401380, X05418562, and X05419556 PATELLA TRI-PEG "FPV EVOS" RIGHT SIZE 41, PGA20018, Lot Numbers: X03397145, X04400214, X04401213, X05401381, and X05418563 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 35, PGA20024, Lot Number: X07429260 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 38, PGA20026, Lot Numbers: X03397148, X04400217, X04401217, X05401384, and X05418557 PATELLA TRI-PEG "FPV EVOS" LEFT SIZE 41, PGA20028, Lot Numbers: X03397149, X04400218, X04401218, X05401385, and X05418559 TROCHLEA "FPV EVOS" RIGHT SIZE 3, PGA20116, Lot Number: X05427577 TROCHLEA "FPV EVOS" RIGHT SIZE 4, PGA20118, Lot Numbers: X03397138, X05427571, X05427578, and X07428738 TROCHLEA "FPV EVOS" LEFT SIZE 3, PGA20126, Lot Numbers: X05427573 and X05427582 TROCHLEA "FPV EVOS" LEFT SIZE 4, PGA20128, Lot Numbers: X03397141, X05427567, X05427574, X05427583, X0542758310, and X07427587 PLAT. TIBIAL TITANE IB II-59 S/CIMENT EQUIPE, PPB21002, Lot Number: W11373017 PLAT. TIBIAL TITANE IB II-69 S/CIMENT EQUIPE, PPB21006, Lot Number: W01278824 PLAT. TIBIAL TITANE IB II-74 S/CIMENT EQUIPE, PPB21008, Lot Numbers: V0281306 and V1128727 2 VIS POUR PLATEAU TIBIAL S/C IB II:D=5.5*20 (TITANE), PPB22000, Lot Number: X04418520 PLAT. TIBIAL TITANE IB II-54 A/CIMENT EQUIPE, PPB30030, Lot Number: W09359212 PLAT. TIBIAL TITANE IB II-59 A/CIMENT EQUIPE, PPB30034, Lot Number: W11373000 PLATEAU TIBIAL PE IB II-64 8.5, PPB30140, Lot Numbers: V12278842, W01301110, W03308823, W05327953, W07350813, and W09359226 PLATEAU TIBIAL PE IB II-64 10, PPB30142, Lot Numbers: V11272779 and W01288273 PLATEAU TIBIAL PE IB II-64 12.5, PPB30144, Lot Numbers: V09243783, W01278844, and W09359228 PLATEAU TIBIAL PE IB II-64 17.5, PPB30148, Lot Numbers: W06335185 and W06344258 PLATEAU TIBIAL PE IB II-64 20, PPB30150, Lot Number: V05194572 PLATEAU TIBIAL PE IB II-69 8.5, PPB30160, Lot Numbers: V11272780 and W01278845 PLATEAU TIBIAL PE IB II-69 10, PPB30162, Lot Numbers: V09243785, V09244054, and W01278846 PLATEAU TIBIAL PE IB II-69 12.5, PPB30164, Lot Numbers: V10278847 and W11386265 PLATEAU TIBIAL PE IB II-74 8.5, PPB30180, Lot Numbers: V0352781 and W01302929 PLATEAU TIBIAL PE IB II-74 22.5, PPB30192, Lot Number: V02132239 ROTULE EN PE IB II D=32 , PPB30300, Lot Numbers: W07350818 and W09359229 ROTULE EN PE IB II D=38 , PPB30306, Lot Number: V08215499 CALE TIBIALE OBLIQUE IB II 54 X 15 DEGRES TITANE, PPB30332, Lot Number: W10922773 CALE TIBIALE OBLIQUE IB II 64 X 7.5 DEGRES TITANE, PPB30350, Lot Number: V0976523 1/2 CALE OBLIQUE IB II-54 28 DEGRES, PPB30390, Lot Numbers: V0981333 and V1135070 1/2 CALE OBLIQUE IB II-64 28 DEGRES, PPB30394, Lot Number: V07112693 CALE FEMORALE POSTERIEURE IB II-64 H=5, PPB30664, Lot Number: V02132301 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 8.5, PPB30720, Lot Number: W06327711 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 12.5, PPB30724 Lot Number: V12277380 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 15, PPB30726, Lot Number: V0182012 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 17.5, PPB30728, Lot Number: V12277381 PLAT. TIBIAL PE IB II-54- CONDYLAR CONS. 20, PPB30730, Lot Number: V0181339 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 10, PPB30742, Lot Number: W10372866 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 22, PPB30752, Lot Number: W01301118 PLAT. TIBIAL PE IB II-59- CONDYLAR CONS. 25, PPB30754, Lot Number: V12300716 and W03314294 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 8.5, PPB30760, Lot Number: W09359233 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 10, PPB30762, Lot Number: W03301119 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 15, PPB30766, Lot Number: W09359234 PLAT. TIBIAL PE IB II-64- CONDYLAR CONS. 25, PPB30774, Lot Number: W03301120 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 8.5, PPB30780, Lot Number: V01116191 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 12.5, PPB30784, Lot Number: V01100282 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 22, PPB30792, Lot Numbers: V12287374 and W03314295 PLAT. TIBIAL PE IB II-69- CONDYLAR CONS. 25, PPB30794, Lot Numbers: W02306633 and W0590706
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|---|---|---|---|
| Z-0393-2022 | Class II | Stryker DARCO Screw, Locking, Ti6A14V, REF DC28... | Dec 3, 2021 |
| Z-0392-2022 | Class II | Stryker CLAW II ORTHOLOC 3DSi Plate, Hole Qty: ... | Dec 3, 2021 |
| Z-0316-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT S... | Nov 4, 2021 |
| Z-0315-2022 | Class II | INBONE Total Ankle System, INBONE POLY INSERT S... | Nov 4, 2021 |
| Z-2989-2020 | Class II | EVOLVE STEM 8.5MM Model # 496S085 | Aug 26, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.