BEUDAMED
    FDA Recall Terminated

    FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.

    Recall: Z-2466-2008 · Initiated August 4, 2008

    Recall

    Recall Number
    Z-2466-2008
    Event Number
    49116
    FEI Number
    1000116912
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    August 4, 2008
    Posted
    September 29, 2008
    Terminated
    August 3, 2009
    Address
    9800 Metric Blvd, Encore Medical, Lp, Austin, TX, 78758

    Description

    FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.

    Reason

    Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.

    Action

    Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.

    Distribution

    FL and TX and OUS: Japan.

    Quantity

    68 units.