Recall Z-0463-2008 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Howmedica Osteonics Corp.
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
| Date | Dec 14, 2007 (initiated Sep 28, 2007) |
| Status | Terminated |
| Reason | Mis-labeled: The warning label "Do not use with heads more than +10mm offset" does not appear on 127 degree stem boxes. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 59 |
| Distribution | Nationwide- USA including states of OR, AZ, NV, MI, AL, MI, FL, MN, and CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063822 | MODIFICATION TO HIPSTAR FEMORAL STEM Stryker Orthopaedics, Jan 25, 2007 |