BEUDAMED
    FDA Recall Terminated

    Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.

    Recall: Z-0779-2010 · Initiated December 22, 2009

    Recall

    Recall Number
    Z-0779-2010
    Event Number
    54141
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 22, 2009
    Posted
    February 2, 2010
    Terminated
    October 22, 2010
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, Biomet Sports Medicine, Warsaw, IN; REF 907320.

    Reason

    The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.

    Action

    Hospitals, distributors, and other customers were notified by letter dated 12/22/09 and instructed to locate and return these lots of product. Questions related to this notice should be directed to the firm at 800-348-9500 or 574-372-3983, Monday through Friday, 8AM to 5PM.

    Distribution

    Arkansas, California, Delaware, Florida, Kansas, Kentucky, Michigan, Missouri, New York, Pennsylvania, South Dakota, Texas, Washington, Wisconsin, Chile, Germany, Italy, Japan and Norway.

    Quantity

    169