BEUDAMED
    FDA Recall Terminated

    Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland.

    Recall: Z-0965-2008 · Initiated November 2, 2007

    Recall

    Recall Number
    Z-0965-2008
    Event Number
    45902
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    JDI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 2, 2007
    Posted
    February 7, 2008
    Terminated
    August 30, 2010
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland.

    Reason

    Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.

    Action

    Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.

    Distribution

    Nationwide Distribution

    Quantity

    5,599 total units