BEUDAMED
    FDA Recall 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.

    Recall: Z-0962-2009 · Initiated December 19, 2008

    Recall

    Recall Number
    Z-0962-2009
    Event Number
    50699
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    NRA
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 19, 2008
    Posted
    February 3, 2009
    Terminated
    July 7, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    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.

    Reason

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

    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.

    Distribution

    Massachusetts and West Virginia.

    Quantity

    2