RecallRadar

FDA Device recall Z-0452-2014

Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur

On 2013-12-11 the FDA classified a Class II recall of Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur by Synthes Usa Hq, citing two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0452-2014
ClassificationClass II
Statusterminated
Initiated2013-07-30
Published2013-12-11
Last updated2026-09-13 11:53 UTC
CompanySynthes Usa Hq
DistributionUS

Product

Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.

Reason

Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail.

Identifiers

code_infoPart # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0452-2014%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.