CLASS II Device recall · Reported 11 Dec 2013 · FDA Enforcement Report

Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ

Synthes USA HQ is recalling Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable, distributed nationwide in the US. The recall was initiated on 30 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart # 456.391S with lot numbers 5536930, exp. 5/20/2016, and 7161401, exp. 12/31/2021.

Quantity recalled17

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0452-2014
FDA event ID: 66417
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2013
FDA classified: 4 Dec 2013
Reported: 11 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

30 Jul 2013	Recall initiated by company
4 Dec 2013	Classified by FDA	+127 days
11 Dec 2013	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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

Where it was distributed

Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.

Nationwide Arizona California Florida Illinois Montana New Mexico New York Texas Utah Virginia

Questions about this recall

Is Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable recalled?

Yes. Synthes USA HQ recalled Titanium Trochanteric Fixation Nail (TFN)System Intended to treat stable and unstable on 30 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0452-2014.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

Nationwide Distribution including IL, CA, AZ, FL, TX, UT, VA, NY, NM, and MT.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Synthes USA HQ

All 56

Reported	Class	Recall	Company	Reason	Where
8 Jan 2014Device	CLASS II	Synthes Hand Switch - Electric Pen Drive recalled by Synthes USA HQ	Synthes USA HQ	Foreign Material	Nationwide
18 Dec 2013Device	CLASS II	Synthes TomoFix Plates The Synthes J5606-C TomoFix recalled	Synthes USA HQ	Other	Nationwide
18 Dec 2013Device	CLASS II	Synthes Trochanteric Fixation Nail As part of the Synthes recalled	Synthes USA HQ	Labeling Errors	Nationwide
11 Dec 2013Device	CLASS II	Synthes Soft Tissue Retractor Small Extendible recalled	Synthes USA HQ	Device Malfunction	Nationwide
11 Dec 2013Device	CLASS II	Synthes Zero-P VA Implant Height Parallel Sterile recalled	Synthes USA HQ	Sterility	Nationwide

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