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Terminated

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.

FDA Recall Z-0962-2009 · Posted 2009-02-03

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeNRA
Date Initiated2008-12-19
Date Terminated2009-07-07
Product Quantity2

Reason for Recall

Packages labeled as "right" actually contain a "left" component.

Firm Action

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

Distribution Pattern

Massachusetts and West Virginia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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