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Recall Observatory FDA recall evidence

Device product

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

Z-0922-2013

September 18, 2012

Class II

Product summary

Firm
Instratek, Incorporated
Event
Event 63551
Status
Terminated
Classification
Class II
Quantity
235
Official record key
device-enforcement:Z-0922-2013

Official wording

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.

Code information: Model number 1052; Lots M674180, MAKL170, M674200

Distribution pattern: USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.