Recall Z-0389-2010 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Smith & Nephew Inc
Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
| Date | Nov 20, 2009 (initiated Jan 23, 2009) |
| Status | Terminated |
| Reason | Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision. |
| Root cause | Other |
| Action | All affected Smith & Nephew Sales Representatives were notified of problem and the recall overnight mail on 01/23/2009. All affected Smith & Nephew International Distributors were notified via email and telephone on 01/23/2009. They were instructed to immediately quarantine the product for return. Further questions are directed to the contacts at Smith and Nephew listed in the letter. |
| Quantity | 925 units |
| Distribution | Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030766 | OXINIUM FEMORAL HEADS Smith & Nephew, Inc., Jul 25, 2003 |