CLASS II Device recall · Reported 20 Mar 2013 · FDA Enforcement Report

Endotrig Trigger Release Sterile Micro Hook Blade recalled

Instratek, Incorporated is recalling Endotrig Trigger Release Sterile Micro Hook Blade, distributed nationwide in the US. The recall was initiated on 18 Sep 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel number 1052; Lots M674180, MAKL170, M674200

Quantity recalled235

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-0922-2013
FDA event ID: 63551
Recalling firm: Instratek, Incorporated, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 18 Sep 2012
FDA classified: 8 Mar 2013
Reported: 20 Mar 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

18 Sep 2012	Recall initiated by company
8 Mar 2013	Classified by FDA	+171 days
20 Mar 2013	Published in enforcement report	+12 days

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

Reason for recall

Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.

Where it was distributed

USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.

Nationwide Arizona Michigan Nebraska Nevada Texas

Questions about this recall

Is Endotrig Trigger Release Sterile Micro Hook Blade recalled?

Yes. Instratek, Incorporated recalled Endotrig Trigger Release Sterile Micro Hook Blade on 18 Sep 2012. The recall is Class II and its status is Terminated. Recall number Z-0922-2013.

Why was it recalled?

Which lots are affected?

Model number 1052; Lots M674180, MAKL170, M674200

Where was it sold?

USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.

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 Instratek, Incorporated

All 3

Reported	Class	Recall	Company	Reason	Where
30 Dec 2015Device	CLASS II	Hook Blade, Angled recalled by Instratek, Incorporated	Instratek, Incorporated	Sterility	4 states
1 Oct 2014Device	CLASS II	Mini Cannulated Titanium Headed and Headless Screw Set recalled	Instratek, Incorporated	Other	Nationwide

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