BEUDAMED
    FDA Recall Terminated

    LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

    Recall: Z-1241-2015 · Initiated February 3, 2015

    Recall

    Recall Number
    Z-1241-2015
    Event Number
    70338
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 3, 2015
    Posted
    March 3, 2015
    Terminated
    April 7, 2017
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip stem trunnion during surgery for a total hip arthroplasty.

    Reason

    Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.

    Action

    Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.

    Distribution

    Distributed in the states of GA, MA, NC, NY & PA.

    Quantity

    9 units