BEUDAMED
    FDA Recall Terminated

    Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem

    Recall: Z-0588-03 · Initiated January 7, 2003

    Recall

    Recall Number
    Z-0588-03
    Event Number
    25460
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 7, 2003
    Posted
    February 27, 2003
    Terminated
    July 31, 2003
    Address
    300 Commerce Court, Mahwah, NJ, 07430

    Description

    Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem

    Reason

    Some components have disassociated post-operatively resulting in additional surgery to the patient.

    Action

    Notification letters were sent to Howmedica sales agents and Operating Room Supervisors via FedEx on 1/7/2003. On 2/12/2003, Howmedica again sent out notification letters on the extended recalled devices.

    Distribution

    The devices were distributed nationwide to Howmedica branches/agents, hospitals, one government hospital and internationally.

    Quantity

    311