Synthes USA HQ, Inc. recalls Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Hel

Recalled November 27, 2013 · FDA recall Z-0369-2014 · Synthes USA HQ

Hazard

A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. · FDA Class II

Units

350195

Sold at

Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.

Description

A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.

Product

Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade is used to treat stable and unstable fractures of the proximal femur including pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations thereof. The long TFN is additionally indicated for subtrochanteric fractures, pertrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in both trochanteric and diaphyseal regions, long subtrochanteric fractures, proximal or distal non-unions, malunions, and revisions.

Manufacturer(s)

Synthes USA HQ, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →