Recall Z-2299-2008 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Zimmer Inc.
Zimmer Metasul Head 32/-4'S', taper 12/14, hip implant component; REF 19.32.05.
| Date | Sep 17, 2008 (initiated Jun 30, 2008) |
| Status | Terminated |
| Reason | The wrong part may be in the package. Package may contain a 28 mm head. |
| Root cause | Packaging process control |
| Action | Zimmer notified consignees via recall letter dated 6/20/08 to return the product. |
| Quantity | 4 |
| Distribution | Florida, Pennsylvania, Texas and Virginia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033634 | EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED Centerpulse Orthopedics, Inc., Sep 15, 2004 |