Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to rel...

FDA Device Recall #Z-0922-2013 — Class II — September 18, 2012

Recall Summary

Recall Number Z-0922-2013
Classification Class II — Moderate risk
Date Initiated September 18, 2012
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Instratek, Incorporated
Location Houston, TX
Product Type Devices
Quantity 235

Product Description

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

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.

Distribution Pattern

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

Lot / Code Information

Model number 1052; Lots M674180, MAKL170, M674200

Other Recalls from Instratek, Incorporated

Recall # Classification Product Date
Z-0469-2016 Class II Hook Blade, Angled. Part number 7058A. Steril... Nov 24, 2015
Z-2679-2014 Class II Mini Cannulated Titanium Headed and Headless Sc... Apr 25, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.