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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Product Detail

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.
Recall Number Z-0922-2013
Classification Class II
Code Info Model number 1052; Lots M674180, MAKL170, M674200
Product Distributed Qty 235
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.

Event Detail

Event Id 63551
Product Type Devices
Status Ongoing
Recalling Firm Instratek, Incorporated
City Houston
State TX
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-09-18
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.