Events

Recall of Multiple Polishing Products containing Optrapol (a dental polishing system)

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-00906-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00906-1
  • 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
    As a precautionary measure, ivoclar vivadent is recalling certain products. the affected polisher may suffer increased wear during use.This action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Ivoclar Vivadent advised users to check stock and return the affected product for credit. This action has been closed-out on 20/11/2017.

Device

Multiple Polishing Products containing Optrapol (a dental polishing system)
  • Model / Serial
    Multiple Polishing Products containing Optrapol (a dental polishing system)Products affected: OptraPol Small Flame, OptraPol PromoPack, OptraPol TestPack, OptraPol Assortment, OptraPol Cuo Refill, Tetric N-Ceram System Kit A2/N Uv.6g, Telio CS C&B; Starter Kit A2, Direct Restoratives Workshop Kit, Composite Workshop Kit (Emp. Bulk Fill)Multiple Article and Lot Numbers affectedARTG Number: 106523
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd