FDA-Device2016-09-21Class II
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 malu
Stryker Howmedica Osteonics Corp.
Hazard
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Sold states
US distribution to state of: CA.
Affected count
1 unit in total
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2791-2016Don't want to check this manually?
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