Z-2791-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

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