BEUDAMED
    FDA Recall Terminated

    Citation AT Femoral Stem

    Recall: Z-0109-06 · Initiated August 24, 2005

    Recall

    Recall Number
    Z-0109-06
    Event Number
    33361
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MAY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2005
    Posted
    November 1, 2005
    Terminated
    April 5, 2006
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Citation AT Femoral Stem

    Reason

    The V40 femoral head may not properly engage on the referenced V40 cobal chrome femoral hip stems.

    Action

    A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.

    Distribution

    nationwide

    Quantity

    207 units