CLASS II Device recall · Reported 22 Jul 2015 · FDA Enforcement Report

Helical Blade Inserter for Trochanteric Fixation recalled

Synthes (USA) Products is recalling Helical Blade Inserter for Trochanteric Fixation Nail-Advanced (Tfna), distributed nationwide in the US. The recall was initiated on 10 Jun 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number Lot Numbers 03.037.024 T102759

Quantity recalled32

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-2091-2015
FDA event ID: 71492
Recalling firm: Synthes (USA) Products, West Chester, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jun 2015
FDA classified: 16 Jul 2015
Reported: 22 Jul 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

10 Jun 2015	Recall initiated by company
16 Jul 2015	Classified by FDA	+36 days
22 Jul 2015	Published in enforcement report	+6 days

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

Reason for recall

The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).

Product as listed by the FDA

Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Part Number Lot Numbers 03.037.024 T102759

Where was it sold?

Nationwide Distribution.

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

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