CLASS II Device recall · Reported 18 Dec 2013 · FDA Enforcement Report

Synthes Trochanteric Fixation Nail As part of the Synthes recalled

Synthes USA HQ is recalling Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail, 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 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Quantity recalled12

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-0474-2014
FDA event ID: 66409
Recalling firm: Synthes USA HQ, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 30 Jul 2013
FDA classified: 10 Dec 2013
Reported: 18 Dec 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

30 Jul 2013	Recall initiated by company
10 Dec 2013	Classified by FDA	+133 days
18 Dec 2013	Published in enforcement report	+8 days

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

Reason for recall

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Product as listed by the FDA

Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail (TFN) System, the TFN Nail is intended to treat stable and unstable fractures of the proximal femur.

Where it was distributed

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

Nationwide California Florida Georgia Indiana Louisiana Michigan Ohio Pennsylvania Texas Washington

Questions about this recall

Is Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail recalled?

Yes. Synthes USA HQ recalled Synthes Trochanteric Fixation Nail As part of the Synthes Trochanteric Fixation Nail on 30 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-0474-2014.

Why was it recalled?

Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging.

Which lots are affected?

Part 456.475S, lot # 7121831 and Part 456.637S, lot #7121832, expiration 11/30/21.

Where was it sold?

Nationwide Distribution including WA, FL, LA, TX, GA, IN, OH, CA, MI, and PA.

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

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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
11 Dec 2013Device	CLASS II	Synthes Soft Tissue Retractor Small Extendible recalled	Synthes USA HQ	Device Malfunction	Nationwide
11 Dec 2013Device	CLASS II	Titanium Trochanteric Fixation Nail recalled by Synthes USA HQ	Synthes USA HQ	Other	Nationwide
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