BEUDAMED
    FDA Recall Terminated

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    Recall: Z-0266-2013 · Initiated July 3, 2012

    Recall

    Recall Number
    Z-0266-2013
    Event Number
    63273
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 3, 2012
    Posted
    November 8, 2012
    Terminated
    April 17, 2014
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430. The use of external devices provides the surgeon with a means of bone fixation for the management of fracture and reconstructive surgery. These devices are intended only to assist healing and are not intended to replace normal bone structures. External fixation devices are intended to hold fractured bone surfaces in apposition to facilitate normal healing. While proven successful, the devices are manufactured from metal, plastic, and composite materials. No such fracture fixation device, subject to fatigue, can be expected to withstand activity levels in the same way as would a normal health bone. The external fixation system, therefore, will not be as strong, reliable or durable as a normal human bone.

    Reason

    Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.

    Action

    Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated July 2, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Business Reply Form was included for customers to complete and return to via fax to 1-865-252-3635. Contact the firm at 1-866-626-7747 for assistance.

    Distribution

    Nationwide Distribution.

    Quantity

    165 units