BEUDAMED
    FDA Recall Terminated

    Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

    Recall: Z-0227-2009 · Initiated August 20, 2008

    Recall

    Recall Number
    Z-0227-2009
    Event Number
    49484
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LZO
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    August 20, 2008
    Posted
    October 31, 2008
    Terminated
    June 1, 2009
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

    Reason

    The warning label "do not use with heads more than +10, offset" does not appear on 135 degree stem boxes. This warning is contained in the instructions for use.

    Action

    Recall notification letters were sent by Fed Ex on August 20, 2008 to Stryker branches/agencies and Hospital Risk Management departments. Letters to Branches stated the reason for the recall and the potential hazard. Both letters state that it is recommended that physicians follow patients in a manner that is consistent with a physicians routine standard of care for total hip arthroplasty. Contact Stryker Howmedica Osteonics Corp. at 1-201-831-5000 for assistance.

    Distribution

    Nationwide

    Quantity

    77 units