FDAFDA · Food and drugs·Recall number Z-2791-2016
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
Published September 21, 2016 · Recall initiated: June 30, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Distributor
- US distribution to state of: CA.
- Lot
- Catalog number 18220930S and Lot Code K836729
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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