Z-2792-2016 Class II Terminated
FDA device recall Z-2792-2016 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
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
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 18251032S and Lot Code K288335