Finger Joint Implants, Silicone Models TRL-10 and TRL-20
FDA device recall Z-0710-03 · posted 2003-04-09 · Terminated
Recall details
- Recalling firm
- Avanta Orthopaedics, Inc.
- Reason for recall
- Wrong silicone elastomer used in construction.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KYI
- Quantity affected
- 43
- Distribution
- States of CA and UT and to France.
- Date initiated
- 2003-01-24
- Date posted
- 2003-04-09
- Date terminated
- 2004-12-01
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT (K964381) | Avanta Orthopaedics, Inc. | 1997-01-22 |