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Biomet Oxford Unicompartmental Knee, Phase 3, Right Medical… recallZ-0962-2009 · Biomet, Inc. · initiated Dec 19, 2008

Terminated All recalls posted in February 2009

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Packaging process control

What the company is doing

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.

Recall details

Recall number
Z-0962-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 19, 2008
Posted by the FDA
Feb 3, 2009
Recalling firm
Biomet, Inc.
Quantity
2
Product code
NRA
FDA submissions
P010014
Distribution
Massachusetts and West Virginia.

Product description

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.

Code information (models, lots, serial numbers)

Lot 1563796.

Other devices under the same FDA submission

91 devices cleared under P010014 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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