BEUDAMED
    FDA Recall Terminated

    Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.

    Recall: Z-0777-04 · Initiated February 23, 2004

    Recall

    Recall Number
    Z-0777-04
    Event Number
    28433
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 23, 2004
    Posted
    July 20, 2004
    Terminated
    April 13, 2004
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.

    Reason

    The locking ring was not included and the shoulder implanted without the locking ring.

    Action

    The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.

    Distribution

    California, Florida, Washington, Germany and Venezuela.

    Quantity

    7