BEUDAMED
    FDA Recall Terminated

    SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.

    Recall: Z-1684-2011 · Initiated July 13, 2010

    Recall

    Recall Number
    Z-1684-2011
    Event Number
    56332
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 13, 2010
    Posted
    March 16, 2011
    Terminated
    September 29, 2017
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    SCORPIO-FLEX CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.

    Reason

    Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm).

    Action

    Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069. For any questions customers were to call 201-972-2100 or 201-831-5028.

    Distribution

    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.

    Quantity

    159, 095 units, all types