Events

Rappel de ROTULE "913" D32

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Wright Medical Technology Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    63338
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0184-2013
  • Date de mise en oeuvre de l'événement
    2012-09-05
  • Date de publication de l'événement
    2012-10-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2014-01-07
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113530
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
  • Cause
    There may be inaccuracies on the labeled shelf life on all products packaged at the toulon, france facility.
  • 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.

Device

ROTULE "913" D32
  • Modèle / numéro de série
    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
  • Classification du dispositif
    Orthopedic Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • 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.
  • Description du dispositif
    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
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Adresse du fabricant
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002-9501
  • Société-mère du fabricant (2017)
    Wright Medical Group NV
  • Source
    USFDA