Events

Recall of DePuy Synthes Confidence Kit Spinal Cement System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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
    RC-2017-RN-01534-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01534-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    (jjm) is initiating a recall of depuy synthes confidence kit spinal cement system has received reports where the confidence cement products were difficult to visualize on x-ray, or could not be visualized on x-ray. it was identified that the confidence cement kit lots impacted by this field action may contain confidence cement products with incorrect amounts of contrast medium. the contrast medium allows for visualisation of the cement under x-ray imaging.
  • Action
    Johnson & Johnson is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

DePuy Synthes Confidence Kit Spinal Cement System
  • Model / Serial
    DePuy Synthes Confidence Kit Spinal Cement SystemProduct Number: 283910000Confidence Plus Kit Spinal Cement System, 11ccLot Numbers: 133824, 145665, 145664, 135476, 152906Confidence Kit Spinal Cement SystemLot Numbers: 133831, 145669, 152908, 153883, 154956, 154957ARTG Number: 211565
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes