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.
FDA Recall Z-0227-2009 · Posted 2008-10-31
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLZO
Date Initiated2008-08-20
Date Terminated2009-06-01
Product Quantity77 units
Reason for Recall
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.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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