Recall Z-2791-2016 ยท HSB Rod, Fixation, Intramedullary And Accessories
Stryker Howmedica Osteonics Corp.
Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with int
| 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
| K023267 | T2 SUPRACONDYLAR NAIL SYSTEM Howmedica Osteonics Corp., Dec 11, 2002 |