Z-0369-2014 Class II Terminated
FDA device recall Z-0369-2014 was initiated by Synthes USA HQ, Inc. on Oct 3, 2013 and is designated Class II. Reason for recall: A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. The recall status is terminated (terminated Aug 18, 2016). Affected quantity: 350195.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2013
- Initiation Date
- Oct 3, 2013
- Termination Date
- Aug 18, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 350195
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.
Reason for Recall
A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed.
Distribution Pattern
Worldwide Distribution - USA (nationwide) and Internationally to Mexico and Canada.
Code Information
part nos. 456.300-456.310 & 456.650, 456.300S-456.310S & 456.650S, with lot nos. 5615864 through 7423581