Device product
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 intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions
Z-2791-2016
Product summary
- Event
- Event 74727
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit in total
- Official record key
device-enforcement:Z-2791-2016
Official wording
Reason: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Code information: Catalog number 18220930S and Lot Code K836729
Distribution pattern: US distribution to state of: CA.
Derived failure modes
-
Labeling or packaging
incorrectly labeled