—#65279

Product

Hipstar V40 Femoral Stem-127 degrees; Catalog No: 7850-5-001, N degrees 3 high offset 31 mm;Sterile; IMPLANT SIZE 1, Howmedica,Benoist Girard dt Cie, 203 bd de la Grande Della B.P.8;14291 Herouville Saint Clair

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K063822
Affected lot / code info: Lot Numbers: G1312594, G1478915, G1478917, G1565961, and G1589683

Why it was recalled

Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes.

Root cause (FDA determination)

Packaging process control

Action the firm took

Urgent Product Correction/Recall notification letters were sent by Fed Ex return receipt on 9/28/07, requesting quarantine for Styker representatives to return or re-label.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA

Timeline

Recall initiated: 2007-09-28
Posted by FDA: 2007-12-14
Terminated: 2008-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #65279. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.