Z-0922-2013 Class II Terminated
FDA device recall Z-0922-2013 was initiated by Instratek, Incorporated on September 18, 2012 and is designated Class II. 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… The recall status is terminated (terminated April 10, 2013). Affected quantity: 235.
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