FDAFDA · Food and drugs·Recall number Z-0922-2013
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Published March 20, 2013 · Recall initiated: September 18, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Instratek, Incorporated
- Distributor
- USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
- Lot
- Model number 1052; Lots M674180, MAKL170, M674200
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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