—#73591

Product

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 product code: LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051223
Affected lot / code info: Catalog # Lot Code 78501006 G1167520 78501006 G1167521 78501006 G1167521 78501006 G1228787 78501006 G1229912 78501006 G1229912 78501006 G1230461 78501006 G1230461 78501006 G1239108 78501006 G1239108 78501007 G1229913 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501008 G1214896 78501009 G1076126 78501009 G1076126 78501009 G1076126 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1090547 78501009 G1230631 78501009 G1230631 78501010 G1167526 78501010 G1167526 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1214894 78501010 G1285646 78501010 G1285646 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 78501011 GC981487 and 78501012 GC966512

Why it was recalled

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.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430

Distribution

Distribution pattern: Nationwide

Timeline

Recall initiated: 2008-08-20
Posted by FDA: 2008-10-31
Terminated: 2009-06-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73591. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.