Z-0922-2013 Class II Terminated

Recalled by Instratek, Incorporated — Houston, TX

Recall Details

Product Type
Devices
Report Date
March 20, 2013
Initiation Date
September 18, 2012
Termination Date
April 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product 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.

Code Information

Model number 1052; Lots M674180, MAKL170, M674200