Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
FDA device recall Z-0196-2007 · posted 2006-11-21 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
- Action taken
- The recall was initiated on August 31, 2006. The distributors were notified by FAX, email and telephone. The returned devices will be stored quarantine.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 30
- Distribution
- International distribution only---- including countries of South America, Africa and Europe
- Date initiated
- 2006-08-31
- Date posted
- 2006-11-21
- Date terminated
- 2012-05-03
- Location
- Gainesville, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTETRAK B-SERIES TOTAL KNEE SYSTEM (K010434) | Exactech, Inc. | 2001-03-13 |