Events

Recall of Helioseal Clear, 1.25g syringes

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ivoclar Vivadent 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-2016-RN-00156-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-02-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00156-1
  • 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
    Ivoclar vivadent is removing helioseal clear from circulation as a precautionary measure. it cannot be guarrenteed that the material of the affected lot can be sufficiently cured with all polymerization lights. there is no risk to patient health as a result of this issue.
  • Action
    Ivoclar is advising users to stop using the affected product and return. This action has been closed-out on 14/11/2016.

Device

Helioseal Clear, 1.25g syringes
  • Model / Serial
    Helioseal Clear, 1.25g syringesBatch Number: U30755ARTG Number: 98805
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd