Recall Z-1159-2017— Biomet U.K., Ltd.
Class II · Terminated
Class II FDA medical device recall by Biomet U.K., Ltd., initiated 2016-01-05, terminated 2018-06-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System. Reason: 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..
- Recalling firm
- Biomet U.K., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-05
- Terminated
- 2018-06-30
- Firm location
- Bridgend South Wales, N/A, United Kingdom
Product description
Oxford Partial Knee System Left Medial Tibial Trial Tray Size A Product Usage: Instruments for use with the Oxford Uni Partial Knee System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.