Biomet U.K., Ltd.: Zimmer Biomet is conducting a medical device field action for various lot-specific Oxford Knee instruments due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

Agency Publication Date: February 22, 2017

Affected Products

Product: Oxford Knee System Tibial Resector Body Tube & Guides Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-423200, Lots: ZB160602 ZB160701, ZB160801, OXF TIB RESECT BODY TUBE & GD

Product: Oxford Partial Knee System Femoral Slap Hammer Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-422365, Lots:

Product: Oxford Unicompartmental Knee Phase 3 Tibial Impactor Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420932, Lots: ZB160801, ZB160802, ZB160803

Product: Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420826, Lots: ZB160801

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420823 , Lots: ZB160501 ZB160601 ZB160701

Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size F Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420822, Lots: ZB160501 ZB160601 ZB160701

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420821, Lots: ZB160601, ZB160701

Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420820, Lots: ZB160501, ZB160701, ZB160702

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420737, Lots: ZB160501, ZB160601, ZB160801

Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size E Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420736, Lots: ZB160501, ZB160601

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420735, Lots: ZB160501, ZB160601, ZB160801

Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420734, Lots: ZB160501, ZB160601, ZB160802

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item: 32-420733, Lots: ZB160501, ZB160601

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size C Oxford Partial Knee System Left Medial Tibial Trial Tray Size C

Item:32-420732, Lots: ZB160501, ZB160601, ZB160801

Product: Oxford Partial Knee System Right Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420731, Lots: ZB160501, ZB160601, ZB160801

Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420730, Lots: ZB160501, ZB160601, ZB160801

Product: Oxford Unicompartmental Knee Phase 3 Shim Size 3 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420665, Lots: ZB160601, ZB160701

Product: Oxford Unicompartmental Knee Phase 3 Shim Size 2 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420664, Lots: ZB160601, ZB160701

Product: Oxford Unicompartmental Knee Phase 3 Shim Size 1 Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420663, Lots: ZB160601, ZB160701

Product: Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size D Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420060, Lots: ZB160701

Product: Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420059, Lots: ZB160701

Product: Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size C Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420058, Lots: ZB160701

Product: Oxford Partial Knee System Phase 3 Tibial Template Left Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420057, Lots: ZB160701

Product: Oxford Partial Knee System Phase 3 Tibial Template Right Medial Size B Product Usage: Instruments for use with the Oxford Uni Partial Knee System

Item:32-420056, Lots: ZB160701

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 76179

Status: Resolved

Manufacturer: Biomet U.K., Ltd.

Manufactured In: United Kingdom

Units Affected: 24 products (72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72 units in total; 72; 72 units in total; 72 units in total; 72 units in total)

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Sources: FDA iRES · Raw API Response

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