BEUDAMED
    FDA Recall Terminated

    METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672

    Recall: Z-0728-06 · Initiated January 25, 2006

    Recall

    Recall Number
    Z-0728-06
    Event Number
    34653
    Firm
    Medtronic Sofamor Danek Instrument Manufacturing
    FEI Number
    3004564008
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2006
    Posted
    April 12, 2006
    Terminated
    July 5, 2007
    Address
    2975 Brother Blvd, Bartlett, TN, 38133-3957

    Description

    METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672

    Reason

    Due to a manufacturing error after autoclaving the Tubular Retractor coating, Physical Vapor Deposition (PVD) black Titanium Nitride (TiN), may rub off.

    Action

    The firm sent out a recall letter dated January 25, 2006 stating the problem and requesting the return of all unused product.

    Distribution

    IL, IN, MI, CA, Japan, Netherlands

    Quantity

    1