BEUDAMED
    FDA Recall Terminated

    Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.

    Recall: Z-0033-2009 · Initiated May 23, 2008

    Recall

    Recall Number
    Z-0033-2009
    Event Number
    49465
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    May 23, 2008
    Posted
    October 3, 2008
    Terminated
    September 22, 2009
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.

    Reason

    The component in the package is not the correct size.

    Action

    Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.

    Distribution

    USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.

    Quantity

    5