BEUDAMED
    FDA Recall Terminated

    Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

    Recall: Z-2135-2011 · Initiated March 10, 2011

    Recall

    Recall Number
    Z-2135-2011
    Event Number
    58325
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWD
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 10, 2011
    Posted
    May 3, 2011
    Terminated
    February 17, 2012
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE. To provide fixation of any acetabular cup, with appropriate sized screw holes, to the pelvic bone during total hip replacement procedures.

    Reason

    One lot of 30 mm screws was switched with one lot of 25 mm screws.

    Action

    Biomet Orthopedics sent an Urgent Medical Device Recall Notice letter dated March 23, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove the affected lots from their inventory, and return them to Biomet. Complete and enclosed FAX Back Response Form to 574-372-1683 prior to return of product. Distributors were instructed to notify all sub-accounts of the recall. Confirm receipt of notice by calling, 800-348-9500, extension 3755 or 3983. For questions regarding this recall call 574-372-3983, Monday through Friday, 8AM to 5PM.

    Distribution

    Worldwide Distribution - USA including CA, GA, IA, IL, IN, KS, KY, MD, MI, MN, MO, NC, ND, NJ, NY, OK, PA, SD, TX, VA, WA, and WI and the country of Japan.

    Quantity

    100