FDA Medical Device Recalls (openFDA)
Instratek, Incorporated: Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
- Recall number
- Z-0922-2013
- Recalling firm
- Instratek, Incorporated
- Product
- Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
- Status
- Terminated
- Initiated
- 2012-09-18
- Posted
- 2013-03-08
- Terminated
- 2013-04-10
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.
- Quantity
- 235
- Distribution
- USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
- Lot, serial or model codes
- Model number 1052; Lots M674180, MAKL170, M674200
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBH
- Firm FEI
- 1000118334
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28