Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd,
FDA device recall Z-0962-2009 · posted 2009-02-03 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- Packages labeled as "right" actually contain a "left" component.
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- NRA
- Quantity affected
- 2
- Distribution
- Massachusetts and West Virginia.
- Date initiated
- 2008-12-19
- Date posted
- 2009-02-03
- Date terminated
- 2009-07-07
- Location
- Warsaw, IN
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