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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. Model number 1052; Lots M674180, MAKL170, M674200 Class II 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. 235 Z-0922-2013