BEUDAMED
    FDA Recall Terminated

    Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

    Recall: Z-0318-2008 · Initiated September 21, 2007

    Recall

    Recall Number
    Z-0318-2008
    Event Number
    44892
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 21, 2007
    Posted
    December 22, 2007
    Terminated
    June 30, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46581-0587

    Description

    Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe), Biomet, Inc., Warsaw, IN

    Reason

    Loose Screw Component: A screw may come loose and fall from the device during use, and result in implantation with the bone cement.

    Action

    Consignees were notified via Urgent Medical Device Correction letter dated 9/21/07 to assure the screw components are fully seated and secure, to not use any guns with loose or missing screws, and to contact Biomet for instructions to return all instruments for evaluation and refurbishment.

    Distribution

    Worldwide: USA, Canada and Japan.

    Quantity

    6,590 worldwide (2,301 to U.S.) for both recalls Z-0318-0319-2008