BEUDAMED
    FDA Enforcement Class II 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 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1241-2015
    Event ID
    70338
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker Howmedica Osteonics Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    February 3, 2015
    Classification Date
    March 3, 2015
    Termination Date
    April 7, 2017
    Address
    325 Corporate Dr, N/A, Mahwah, NJ, 07430-2002, United States

    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.

    Code Info

    Lot Code 48681201

    Distribution

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

    Quantity

    9 units