Guardian Distal Femur Axial Pin
FDA device recall Z-0523-06 · posted 2006-02-16 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The product was not fully assembled prior to packaging.
- Action taken
- The firm sent out recall notices to implanting surgeons by letter dated 01/10/2005 to notify the surgeons of the issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 10
- Distribution
- Nationwide and PR
- Date initiated
- 2006-01-03
- Date posted
- 2006-02-16
- Date terminated
- 2007-01-29
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUARDIAN LIMB SALVAGE SYSTEM (K013035) | Wrightmedicaltechnologyinc | 2001-12-07 |