Events

Recall of Soft-Core Obturators (Warm bonded endodontic obturation system obturator)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ormco 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-2012-RN-00956-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-09-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00956-1
  • 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
    It has been reported to the sponsor that the boxes labelled as part number 972-3025, which is the size #25 obturators, actually contain inner packages of size #30 obturators. although an inconvenience, the product will function as expected.
  • Action
    Return affected lots to Ormco for replacement with unaffected stock.

Device

Soft-Core Obturators (Warm bonded endodontic obturation system obturator)
  • Model / Serial
    Soft-Core Obturators (Warm bonded endodontic obturation system obturator)Part Number: 972-3025Lot Number: 051257342ARTG Number: 179947
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd