—#76222

Product

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 product code: NRA — Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P010014
Affected lot / code info: Lot 1563796.

Why it was recalled

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

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582

Distribution

Distribution pattern: Massachusetts and West Virginia.

Timeline

Recall initiated: 2008-12-19
Posted by FDA: 2009-02-03
Terminated: 2009-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76222. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.