Events

Recall of Zenostar MT Color and Zenostar MT Color Impulse products

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-00786-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00786-1
  • 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
    The manufacturer has become aware that the primary packaging of the product may show leaks. as a consequence, the liquid may leak from the dropper of the bottle.Direct contact with certain substances contained in this liquid may lead to serious eye damage and/or skin irritation. if contact is made with skin, rinse with water and if irritation continues, seek medical assistance. this action was undertaken prior to consultation with the therapeutic goods administration (tga).
  • Action
    Ivoclar Vivadent is advising users to inspect stock and return.

Device

Zenostar MT Color and Zenostar MT Color Impulse products
  • Model / Serial
    Zenostar MT Color and Zenostar MT Color Impulse productsMultiple product numbers and lot numbers affected.
  • Manufacturer
    Ivoclar Vivadent Pty Ltd

Manufacturer

Ivoclar Vivadent Pty Ltd