Zimmer brand NEXGEN Complete Knee Solution Rotating Hinge Knee Tibial Component, precoat, nonmodular, size 2, sterile, f
FDA device recall Z-1447-04 · posted 2004-09-14 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The polyethylene tibial bushing was omitted from the taper of the tibial plates.
- Action taken
- Consignees were notified via recall letter dated August 3, 2004 and sent via certified mail, return receipt requested. A dear doctor letter dated August 25, 2004 was sent to the implanting physicians.
- Root cause
- Other
- Status
- Terminated
- Product code
- KRO
- Distribution
- Nationwide (California, Florida, Illinois, Indiana, Louisiana, Michigan, Nevada, New Jersey, New York, North Carolina, Ohio, Texas, Wisconsin), and Germany.
- Date initiated
- 2004-08-03
- Date posted
- 2004-09-14
- Date terminated
- 2004-09-13
- 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 |
|---|---|---|
| NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE (K013385) | Zimmer, Inc. | 2002-01-09 |