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Terminated

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

FDA Recall Z-0922-2013 · Posted 2013-03-08

Recalling FirmInstratek, Incorporated
Recall StatusTerminated
Product CodeNBH
Date Initiated2012-09-18
Date Terminated2013-04-10
Product Quantity235

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.

Firm Action

The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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