Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems
FDA device recall Z-2314-2009 · posted 2009-09-24 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- 46 mm Femoral head was mismarked and packaged as being 45 mm
- Action taken
- All affected Smith & Nephew Sales Representatives were notified of problem and sent recall notice in overnight mail on 01/12/2009. All affected Smith & Nephew International Distributors were notified via e-mail and telephone on 01/12/2009. They were instructed to immediately quarantine the product for return. The firm re-issued the letter on 04/06/2009 to address hazard to health. Contact Smith & Nephew, Inc at 1.901.399.6771 if there are any questions.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LZY
- Quantity affected
- 10 units
- Distribution
- CA, FL, MI, and Canada
- Date initiated
- 2009-01-12
- Date posted
- 2009-09-24
- Date terminated
- 2011-03-25
- 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 |