Events

Recall of Fluorocore 2+ Fast Set Core Build Up Dental Material, Syringe- Blue Coloured

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Dentsply (Australia) Pty Ltd.

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-2013-RN-00765-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-07-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00765-1
  • 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
    Dentsply has been advised that two lots (batches) of fluorocore 2+ fast set may exhibit faster setting characteristics than is normal for these products.
  • Action
    Dentsply is requesting users to request a Return Material Authorisation Number and return affected stock

Device

Fluorocore 2+ Fast Set Core Build Up Dental Material, Syringe- Blue Coloured
  • Model / Serial
    Fluorocore 2+ Fast Set Core Build Up Dental Material, Syringe- Blue ColouredItem Number: 612402Lot Numbers: 1209242 and 120904ARTG Number: 144285
  • Manufacturer
    Dentsply (Australia) Pty Ltd

Manufacturer

Dentsply (Australia) Pty Ltd