Recall Z-1295-03 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics
T2 Tibia Nail, Standard 9 x 300 mm, T2 Tibia System, Catalog No. 1822-0930S.
| Date | Oct 15, 2003 (initiated Aug 4, 2003) |
| Status | Terminated |
| Reason | The device does not have an oblong hole for dynamic locking as required. |
| Root cause | Other |
| Action | Product recall letters and Product accountability forms were sent via FedEx on 8/4/2003 with return receipt. |
| Quantity | 6 |
| Distribution | The 6 units were distributed to Howmedica Branch and sales agents located in PA, VA, GA, KS, and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003018 | TITAN TIBIAL NAIL Howmedica Osteonics Corp., Dec 15, 2000 |