Events

Recall of Trigger Finger Blades

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Instratek, Incorporated.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    63551
  • Event Risk Class
    Class 2
  • Event Number
    Z-0922-2013
  • Event Initiated Date
    2012-09-18
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-04-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115088
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Accessories,arthroscopic - Product Code NBH
  • 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.
  • Action
    The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012.

Device

Trigger Finger Blades
  • Model / Serial
    Model number 1052; Lots M674180, MAKL170, M674200
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
  • Product Description
    Endotrig Trigger Release Sterile Micro Hook Blade || Product Usage: || The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
  • Manufacturer
    Instratek, Incorporated

Manufacturer

Instratek, Incorporated
  • Manufacturer Address
    Instratek, Incorporated, 4141 Directors Row, Ste. H, Houston TX 77092-8743
  • Manufacturer Parent Company (2017)
    Instratek Incorporated
  • Source
    USFDA