Recall Z-0922-2013— Instratek, Incorporated
Class II · Terminated
Class II FDA medical device recall by Instratek, Incorporated, initiated 2012-09-18, terminated 2013-04-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.. Reason: 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..
- Recalling firm
- Instratek, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-18
- Terminated
- 2013-04-10
- Firm location
- Houston, TX, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.