BEUDAMED
    FDA Recall Terminated

    Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The nail holding Screw is used to assemble the nail to the target device. The Nail holding Screw is further the mating part (inner thread) of the External Compression Device as the instruments needs to be threaded into the Nail holding Screw in order to achieve Compression at the fracture side.

    Recall: Z-0331-2011 · Initiated August 30, 2010

    Recall

    Recall Number
    Z-0331-2011
    Event Number
    56800
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    HSB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 30, 2010
    Posted
    November 9, 2010
    Terminated
    August 21, 2012
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Nail Holding Screw; 1 unit per package Stryker Trauma GmbH; Distributed by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 The nail holding Screw is used to assemble the nail to the target device. The Nail holding Screw is further the mating part (inner thread) of the External Compression Device as the instruments needs to be threaded into the Nail holding Screw in order to achieve Compression at the fracture side.

    Reason

    Variations in the outer diameter of the shaft of the External Compression Device and the inner diameter of the Nail Holding Screw may make assembly of these 2 instruments not possible.

    Action

    Stryker sent Recall notification letters by Federal Express on September 9, 2010 to all Stryker branches/agencies and Risk Managers, Chief of Orthopaedics of affected hospitals and Surgeons on September 10, 2010, that used the product. The letter identified the product, the problem, and the action that customers should take. Customers were instructed to: Examine their inventory and hospital locations to identify the affected product and return it to their branch or agency warehouse for reconciliation. Reconcile all product on the attached Product Recall Acknowledgment Form and fax a copy to (201) 831-6069 within 5 days of receipt of notice. A Stryker representative would contact the customer with details for return of the product. For any questions regarding this recall call (201) 972-2100.

    Distribution

    Nationwide Distribution including AZ, CA, CO, FL, GA, IL, KY, MD, OH, OK, and TX

    Quantity

    22