BEUDAMED
    FDA Recall Terminated

    Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243

    Recall: Z-1283-03 · Initiated June 18, 2003

    Recall

    Recall Number
    Z-1283-03
    Event Number
    26618
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2003
    Posted
    September 24, 2003
    Terminated
    September 23, 2003
    Address
    56 East Bell Drive, Warsaw, IN, 46582

    Description

    Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243

    Reason

    The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

    Action

    Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.

    Distribution

    United States

    Quantity

    12