Z-2791-2016 Class II Terminated
FDA device recall Z-2791-2016 was initiated by Stryker Howmedica Osteonics Corp. on June 30, 2016 and is designated Class II. Reason for recall: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field. The recall status is terminated (terminated June 21, 2017). Affected quantity: 1 unit in total.
Recall Details
- Product Type
- Devices
- Report Date
- September 21, 2016
- Initiation Date
- June 30, 2016
- Termination Date
- June 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit in total
Product Description
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
Reason for Recall
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Distribution Pattern
US distribution to state of: CA.
Code Information
Catalog number 18220930S and Lot Code K836729