Events

Recall of Ivoclar Vivadent Helioseal Clear

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Ivoclar Vivadent AG.

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
    19730
  • Event Initiated Date
    2016-02-10
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Ivoclar Vivadent Ltd, 12 Omega Street, Albany, AUCKLAND
  • Reason
    A wrong photo-initiator was used in the a production batch of product. this failure can lead to incomplete curing of the sealant, if mono-wave led curing lights are used.
  • Action
    Product to be returned to supplier

Device

Ivoclar Vivadent Helioseal Clear

Manufacturer

Ivoclar Vivadent AG