BEUDAMED
    FDA Recall Terminated

    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.

    Recall: Z-0874-2009 · Initiated December 18, 2008

    Recall

    Recall Number
    Z-0874-2009
    Event Number
    50698
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HTZ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 18, 2008
    Posted
    January 13, 2009
    Terminated
    January 20, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.

    Reason

    Falling component: The universal pin, which holds the sliding instrument saw guide in its slot, may loosen during surgical procedures and fall into the wound.

    Action

    Consignees were notified by letter entitled "URGENT MEDICAL DEVICE REMOVAL NOTICE" dated 12/18/08 advising them of the problem and that the instruments should be removed from use and returned. For further information, please contact Biomet, Inc., by telephone on 800-348-9500.

    Distribution

    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.

    Quantity

    444 of all products