Events

Recall of INSTATRAK 3500 SYSTEM

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

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
    149854
  • Event Risk Class
    II
  • Event Initiated Date
    2007-04-04
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Weld between the post body and the screw was not properly formed and may fail even when minimal force is used which could result in the screw having to be removed from the bone by other means.

Device

INSTATRAK 3500 SYSTEM
  • Model / Serial
    Model Catalog: 1006236-001 (Lot serial: IT35071); Model Catalog: 1006236-001 (Lot serial: IT35079 IT35214P CS535P); Model Catalog: 1006236-001 (Lot serial: S/N'S IT35226P)
  • Product Description
    OEC INSTATRAK 3500
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)