Recall Z-2792-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar f
| Date | Sep 13, 2016 (initiated Jun 30, 2016) |
| Status | Terminated |
| Reason | Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. |
| Root cause | Labeling mix-ups |
| Action | The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 30, 2016 by e-mail to its customer requesting that they quarantine affected devices and sent the letter via UPS (with return receipt) on July 1, 2016. The letter described the product, problem and actions to be taken. The customer was instructed to inform users of the Medical Device Removal and forward the notice to all who need to be aware; inspect your inventory and return affected products to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team; 325 Corporate Drive; Dock M-East , Mahwah, NJ 07 |
| Quantity | 1 unit in total |
| Distribution | US distribution to state of: CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010801 | T2 FEMORAL NAIL Howmedica Osteonics Corp., Apr 6, 2001 |