BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.

    Recall: Z-1375-2008 · Initiated February 12, 2008

    Recall

    Recall Number
    Z-1375-2008
    Event Number
    46708
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 12, 2008
    Posted
    July 25, 2008
    Terminated
    December 22, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448.

    Reason

    Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.

    Action

    Distributors were notified via recall letter (Urgent Medical Device Removal Notice) dated 2/12/08 to locate the devices in their possession and at hospital sites, discontinue use, and return them to Biomet. Hospitals having received the devices will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. A third letter dated 2/12/08 was provided for implanting physicians.

    Distribution

    Worldwide: USA and Australia

    Quantity

    4