Events

Recall of Mini Cannulated Titanium Headed and Headless Screw Set

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
    67727
  • Event Risk Class
    Class 2
  • Event Number
    Z-2679-2014
  • Event Initiated Date
    2013-04-25
  • Event Date Posted
    2014-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126167
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    Faded and wrong markings on bone screw countersink/depth gauge instruments in mini screw set.
  • Action
    The firm plans to notify their customers of the recall via email, telephone and visit. The firm then plans to scrap and discard any affected product.

Device

Mini Cannulated Titanium Headed and Headless Screw Set
  • Model / Serial
    Mini System part no. IS1100 - lot 0001-0047; Instrument part nos. IS1103, IS1104, and IS1105 - lots 918101, 918102, and 918103
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide: Maine, Oregon, Florida, Texas, Virginia, Arizona, Nebraska, California, Ohio, Illinois, Oklahoma, Washington, North Carolina, Arkansas, Tennessee, New Mexico, Connecticut, Colorado
  • Product Description
    Mini Cannulated Titanium Headed and Headless Screw Set and 2.5, 3.0, and 4.0 mm countersink/depth gauges in the Mini Screw Set/System
  • Manufacturer
    Instratek, Incorporated

Manufacturer

Instratek, Incorporated
  • Manufacturer Address
    Instratek, Incorporated, 15200 Middlebrook Dr, Ste G, Houston TX 77058-1216
  • Manufacturer Parent Company (2017)
    Instratek Incorporated
  • Source
    USFDA