Events

Recall of FT SERIES ELECTRODES

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by INTEGRA CANADA ULC..

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
    40151
  • Event Risk Class
    II
  • Event Initiated Date
    2010-09-10
  • 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
    Under extreme conditions of vigorous shaking of the package or enough shock/kinetic energy apply to package in a certain way the product potentially can pierce the tyvek pouch. the product is gamma irradiated for sterilization purposes and puncturing of the tyvek pouch will compromise the sterility of the product.

Device

FT SERIES ELECTRODES
  • Model / Serial
    Model Catalog: FT-S (Lot serial: 40878); Model Catalog: FT-S/S (Lot serial: 40878); Model Catalog: FT-S (Lot serial: 39662); Model Catalog: FT-S/S (Lot serial: 39662)
  • Product Description
    FT SERIES ELECTRODES
  • Manufacturer
    INTEGRA CANADA ULC.

Manufacturer

INTEGRA CANADA ULC.