Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; . Unicompartmental knee joint replacement system. Designed to allow for motion between the plastic tibial bearing and metal tibial baseplate components of a unicompartmental knee prosthesis.
This recall has been terminated (originally issued February 3, 2009).
- Company
- Biomet, Inc.
- Recall Initiated
- December 19, 2008
- Posted
- February 3, 2009
- Terminated
- July 7, 2009
- Recall Number
- Z-0962-2009
- Quantity
- 2
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
Packages labeled as "right" actually contain a "left" component.
Distribution
Massachusetts and West Virginia.
Lot / Code Info
Lot 1563796.
Root Cause
Packaging process control
Action Taken
Biomet salesmen were notified by phone and instructed to retrieve the products. One customer was notified by letter dated 12/19/08 that use of the product should cease and that a salesman would pick up the product. A second customer had implanted the product and was hand delivered a letter dated 12/19/08 instructing that the patient should be monitored and symptoms treated as necessary. Contact Biomet at 574-362-3983 for assistance.
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