Recall Z-0710-03 ยท KYI Prosthesis, Wrist, Carpal Trapezium
Avanta Orthopaedics, Inc.
Finger Joint Implants, Silicone Models TRL-10 and TRL-20
| Date | Apr 9, 2003 (initiated Jan 24, 2003) |
| Status | Terminated |
| Reason | Wrong silicone elastomer used in construction. |
| Root cause | Other |
| Action | Recall was initiated by telephone on 1/24/2003. All customers responded by 1/28/2003. All units have been accounted for. The units have been returned. The recall is complete. |
| Quantity | 43 |
| Distribution | States of CA and UT and to France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT Avanta Orthopaedics, Inc., Jan 22, 1997 |