BEUDAMED
    FDA Recall Terminated

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    Recall: Z-0470-2008 · Initiated September 28, 2007

    Recall

    Recall Number
    Z-0470-2008
    Event Number
    45334
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    September 28, 2007
    Posted
    December 14, 2007
    Terminated
    October 27, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Sterile; Catalog No: 7850-5-008, IMPLANT SIZE 8 , Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

    Reason

    Mis-labeling: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

    Action

    Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.

    Distribution

    Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA

    Quantity

    43