Recalls / —
—#66609
Product
Hipstar V40 Femoral Stem-127 degrees; N degrees 3 high offset 31 mm;Catalog No: 7850-5-005, IMPLANT SIZE 5, Sterile; 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
- Affected lot / code info
- Lot Number: G1312701, G1479782, G1479783, G1540972, G1560387, G1576137, G1576139, G1615995, G1615996, G1618366, and G1618367
Why it was recalled
Mis-labeling; 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 #66609. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.