Guardian Distal Femur Axial Pin
FDA device recall Z-1405-04 · posted 2004-08-24 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- Potential for self -locking axial pin to dislodge and 'back out'.
- Action taken
- The firm sent out product correction notifications to implanting surgeons by letter dated 07/14/2004 to notify the surgeons of the dislodgement issue.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 44
- Distribution
- Nationwide. Ontario, and Taiwan, ROC
- Date initiated
- 2004-07-14
- Date posted
- 2004-08-24
- Date terminated
- 2005-07-05
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GUARDIAN LIMB SALVAGE SYSTEM (K013035) | Wrightmedicaltechnologyinc | 2001-12-07 |