BEUDAMED
    FDA Recall Terminated

    T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ

    Recall: Z-0481-2011 · Initiated August 2, 2006

    Recall

    Recall Number
    Z-0481-2011
    Event Number
    50117
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2006
    Posted
    November 26, 2010
    Terminated
    November 22, 2013
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    T2 Ankle Arthrodesis System Nail and Nut Adapter; Stryker Trauma GmbH, Germany; Distributed in USA by Howmedica, Osteonics Corp., 325 Corporate Drive, Mahwah, NJ

    Reason

    The thread of the nut which should fix the nail adaptor to the targeting arm may seize on the threat of the nail adaptor, interrupting surgery.

    Action

    Stryker Orthopedics issued an Important Stock Recovery letter dated August 2, 2006 The customer was instructed to inspect inventory for the affected product and return it to the firm. The customer was asked to complete and return a Product Accountability Form and contact their Stryker representative for replacement product. Stryker can be contacted about this issue at 201 831-5118.

    Distribution

    Nationwide Distribution: To one location in New Jersey.

    Quantity

    8 sets