FDAClass IIDecember 11, 2013

Titanium Trochanteric Fixation Nail recall

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

Why was Titanium Trochanteric Fixation Nail recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable fractures of the proximal femur.
Recalling firm
Synthes USA HQ, Inc.
Quantity
17
Distribution
Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.
Recall date
December 11, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls