Recall Z-2314-2009 ยท LZY Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Smith & Nephew Inc
Tandem Unipolar, 46 MM CO-CR, REF 126646, Sterile, Smith & Nephew, Memphis TX 38116 Designed for use with femoral stems and acetabular components distributed by Smith & Nephew.
| Date | Sep 24, 2009 (initiated Jan 12, 2009) |
| Status | Terminated |
| Reason | 46 mm Femoral head was mismarked and packaged as being 45 mm |
| Root cause | Process control |
| Action | 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. |
| Quantity | 10 units |
| Distribution | CA, FL, MI, and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030766 | OXINIUM FEMORAL HEADS Smith & Nephew, Inc., Jul 25, 2003 |