BEUDAMED
    FDA Recall Terminated

    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

    Recall: Z-0695-2013 · Initiated October 25, 2012

    Recall

    Recall Number
    Z-0695-2013
    Event Number
    63863
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 25, 2012
    Posted
    January 17, 2013
    Terminated
    December 1, 2015
    Address
    325 Corporate Drive, Mahwah, NJ, 07430

    Description

    Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.

    Reason

    Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.

    Action

    Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service.

    Distribution

    Nationwide Distribution, including the states of PA, OH, NY, CA and IL.

    Quantity

    476 units