T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
FDA device recall Z-1295-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics
- Reason for recall
- The device does not have an oblong hole for dynamic locking as required.
- Action taken
- Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt.
- Root cause
- Other
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 6
- Distribution
- The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA.
- Date initiated
- 2003-08-04
- Date posted
- 2003-10-15
- Date terminated
- 2003-09-30
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TITAN TIBIAL NAIL (K003018) | Howmedica Osteonics Corp. | 2000-12-15 |