Recall Z-0922-2013
Instratek, Incorporated · initiated September 18, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Codes / lots: Model number 1052; Lots M674180, MAKL170, M674200
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.
Details
- Recall number
- Z-0922-2013
- Initiated
- September 18, 2012
- Posted by FDA
- March 8, 2013
- Terminated
- April 10, 2013
- Product code
- NBH – Accessories, Arthroscopic
- Quantity
- 235
- Distribution
- USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
- Recalling firm
- Instratek, Incorporated, Houston, TX