Z-0922-2013Class II

Endotrig Trigger Release Sterile Micro Hook Blade

Name: Z-0922-2013 Endotrig Trigger Release Sterile Micro Hook Blade
Creator: Instratek, Incorporated
Published: 2012-09-18
License: https://open.fda.gov/license/

Instratek, Incorporated / initiated 2012-09-18 / Terminated / root cause: manufacturing process

FDA source

Instratek, Incorporated began a recall of Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures on 2012-09-18. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0922-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-18
Posted: 2013-03-08
Terminated: 2013-04-10
Recalling firm: Instratek, Incorporated
Product: Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Product code: NBH Accessories, Arthroscopic
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.
Quantity in commerce: 235
Distribution: USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
Product codes and lots: Model number 1052; Lots M674180, MAKL170, M674200

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0922-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0922-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-08

Product code NBH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)