Device product
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 fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
Z-2792-2016
Product summary
- Event
- Event 74727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit in total
- Official record key
device-enforcement:Z-2792-2016
Official wording
Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Code information: Catalog number 18251032S and Lot Code K288335
Distribution pattern: US distribution to state of: CA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled