Recall Z-2792-2016— Stryker Howmedica Osteonics Corp.

Name: FDA recall Z-2792-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-30

Class II · Terminated

Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-06-30, terminated 2017-06-21. It names one FDA 510(k) clearance: K010801. Product: 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: Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field..

Recalling firm: Stryker Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2016-06-30
Terminated: 2017-06-21
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K010801 — T2 FEMORAL NAILHowmedica Osteonics Corp.·cleared 2001-04-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.