BEUDAMED
    FDA Recall Terminated

    Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.

    Recall: Z-1361-2008 · Initiated February 12, 2008

    Recall

    Recall Number
    Z-1361-2008
    Event Number
    46706
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWT
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 12, 2008
    Posted
    March 28, 2008
    Terminated
    June 26, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Vanguard Width Checker, Part Number: 32-487062, 67.5/75 Sizing Wing, Biomet Orthopedics, Inc., Warsaw, IN; The device is a preparatory instrument used for femoral knee insertion.

    Reason

    The instrument's sizing line is in the wrong place.

    Action

    Distributors were notified via Urgent Medical Device Removal Notice letter dated 2/12/08 to locate the instruments in their possession and at hospital sites and to return them to Biomet. Hospitals with the instruments on hand will be provided with a recall letter dated 2/12/08 which describes the nature of the problem and the removal of these instruments. The Puerto Rico consignee was notified by Biomet UK, Ltd. via letter on 2/26/08.

    Distribution

    Worldwide: USA, Canada, China and Finland.

    Quantity

    35 (31 to U.S. and 4 international).