Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0369-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 3, 2013

Date Posted: November 27, 2013

Recall Number: Z-0369-2014

Event ID: 66552

Reason for Recall:

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

Status: Terminated

Product Quantity: 350195

Code Information:

part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated