P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
FDA device recall Z-1369-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Depuy Orthopaedics, Inc.
- Reason for recall
- The collar was incorrectly etched for the R (right) and L (Left) orientation
- Action taken
- Depuy notified distributors at the various territories via verbal contact on 12/23/2003
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 1 unit
- Distribution
- NY
- Date initiated
- 2003-12-22
- 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 |
|---|---|---|
| DARWIN KNEE SYSTEM (TC3) (K952830) | Johnson & Johnson Professionals, Inc. | 1996-01-18 |