Z-0962-2009

Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile...

Name: Z-0962-2009 Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile...
Creator: Biomet, Inc.
Published: 2008-12-19
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2008-12-19 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical Tibial Tray, Standard Size B, CoCr, sterile, Biomet UK Ltd, Bridgend, UK; . Unicompartmental knee... on 2008-12-19. The reason FDA records is "Packages labeled as "right" actually contain a "left" component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0962-2009
Status: Terminated
Initiated: 2008-12-19
Posted: 2009-02-03
Terminated: 2009-07-07
Recalling firm: Zimmer GmbH
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.
Product code: NRA Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing
Reason for recall: Packages labeled as "right" actually contain a "left" component.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 2
Distribution: Massachusetts and West Virginia.
Product codes and lots: Lot 1563796.

Product code NRA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)