Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
FDA device recall Z-0389-2010 · posted 2009-11-20 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 925 units
- Distribution
- Nationwide; 17 international: Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France.
- Date initiated
- 2009-01-23
- Date posted
- 2009-11-20
- Date terminated
- 2012-02-07
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXINIUM FEMORAL HEADS (K030766) | Smith & Nephew, Inc. | 2003-07-25 |