BEUDAMED
    FDA Recall Terminated

    T2 3.5x130mm AO Drill Bit

    Recall: Z-0582-03 · Initiated January 20, 2003

    Recall

    Recall Number
    Z-0582-03
    Event Number
    25585
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    HTW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2003
    Posted
    February 26, 2003
    Terminated
    May 6, 2003
    Address
    300 Commerce Court, Mahwah, NJ, 07430

    Description

    T2 3.5x130mm AO Drill Bit

    Reason

    Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

    Action

    Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.

    Distribution

    Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.

    Quantity

    290