BEUDAMED
    FDA Recall Terminated

    Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany

    Recall: Z-1297-2008 · Initiated January 28, 2008

    Recall

    Recall Number
    Z-1297-2008
    Event Number
    46746
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    January 28, 2008
    Posted
    March 25, 2008
    Terminated
    June 4, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Stryker Orthopaedics, Locking Screw, T7, Catalog Number: 40-27622, Size: 2.7X22MM, Non Sterile,Titanium Alloy; Manufactured and Distributed by: Stryker Leibinger GmbH & Co. KG;Boetzinger Strasse 41; 0-79111 Freiburg, Germany

    Reason

    Screws do not have locking threads

    Action

    Recall notification letters (Urgent Product Recall) were sent on January 28, 2008 to all Stryker Branches/Agencies by Federal Express. All product distributed was requested to be located and returned, including from hospitals.

    Distribution

    Nationwide-USA including states of MA, PA, GA, OH, and TX (hospital consignees) and Stryker Branches/Agencies in MA, NJ, PA, MD, VA, NC, GA, TN, KY, OH, MI, LK, OK, TX, and CA.

    Quantity

    100 units