BEUDAMED
    FDA Recall Terminated

    Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.

    Recall: Z-0825-2010 · Initiated January 6, 2010

    Recall

    Recall Number
    Z-0825-2010
    Event Number
    54238
    Firm
    Synthes USA (HQ), Inc.
    FEI Number
    3005180112
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 6, 2010
    Posted
    February 24, 2010
    Terminated
    October 6, 2010
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.

    Reason

    There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.

    Action

    An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.

    Distribution

    Nationwide Distribution.

    Quantity

    187 units