Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog num
FDA device recall Z-0522-2007 · posted 2007-02-27 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
- Action taken
- Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 4 units
- Distribution
- Distributed to one hospital in New York.
- Date initiated
- 2006-12-07
- Date posted
- 2007-02-27
- Date terminated
- 2012-07-11
- 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 |
|---|---|---|
| EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM (K933494) | Exactech, Inc. | 1995-03-10 |