BEUDAMED
    FDA Recall Terminated

    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK

    Recall: Z-0316-2008 · Initiated June 28, 2007

    Recall

    Recall Number
    Z-0316-2008
    Event Number
    38468
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 28, 2007
    Posted
    December 15, 2007
    Terminated
    March 17, 2008
    Address
    345 E. Main St., Warsaw, IN, 46580-2304

    Description

    Zimmer Minimally Invasive Solutions Technology, Offset Rasp Handle, Left, 45 degrees, non-sterile; REF/Catalog #: 7712-35-01, Zimmer U.K. Ltd., SN3, 4FP, UK

    Reason

    Clip Detachment: The retainer c-clip can detach from the instrument during use and may fall into the surgical wound

    Action

    Zimmer notified their distributors via Product Recall Notification Letter dated 6/30/07 and instructed them to notify their customers of the recall and to pick up the product and return it to Zimmer.

    Distribution

    Worldwide: USA including states of Arizona, California, Florida, Georgia, Indiana, Michigan, New York, North Carolina, and Virginia, and countries of Germany and Japan.

    Quantity

    62 (total for Z-0316-0317-2008)