Events

Recall of IPS E.MAX CERAM GLAZE POWDER REFILL

According to Health Canada (via FOI), this recall involved a device in Canada 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
    93050
  • Event Risk Class
    III
  • Event Initiated Date
    2015-07-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    A number of complaints were received with the issue of coarse particles in the glazed surface of ips e.Max ceram restorations.

Device

IPS E.MAX CERAM GLAZE POWDER REFILL
  • Model / Serial
    Model Catalog: 597044 (Lot serial: T43549); Model Catalog: 597042 (Lot serial: U09829); Model Catalog: 597042 (Lot serial: U15900); Model Catalog: 567761 (Lot serial: U09241); Model Catalog: 597042 (Lot serial: U01578)
  • Product Description
    IPS E.MAX CERAM GLAZE POWDER REFILL
  • Manufacturer
    IVOCLAR VIVADENT AG

Manufacturer

IVOCLAR VIVADENT AG