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Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscop

FDA device recall Z-0922-2013 · posted 2013-03-08 · Terminated

Recall details

Recalling firm
Instratek, Incorporated
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.
Action taken
The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.
Root cause
Nonconforming Material/Component
Status
Terminated
Product code
NBH
Quantity affected
235
Distribution
USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
Date initiated
2012-09-18
Date posted
2013-03-08
Date terminated
2013-04-10
Location
Houston, TX

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