Events

Recall of CONFIDENCE KIT (NEEDLELESS)

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC..

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
    58694
  • Event Risk Class
    II
  • Event Initiated Date
    2017-12-21
  • 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
    Depuy spine is initiating a recall for the removal of specified lots of confidence spinal cement system kits following reports that the confidence cement products were difficult to visualize on x-ray or could not be visualized on x-ray. these products may contain incorrect amounts of contrast medium.

Device

CONFIDENCE KIT (NEEDLELESS)

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.