P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
FDA device recall Z-1382-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- Screw size included in system was incorrect
- Action taken
- DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- IA
- Date initiated
- 2004-01-15
- Date posted
- 2004-08-24
- Date terminated
- 2004-09-23
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS (K923807) | Johnson & Johnson International | 1992-11-09 |