Events

Recall of 3M Lava Ultimate CAD/CAM Restorative

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by 3M ESPE Dental Products.

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
    18707
  • Event Initiated Date
    2015-06-26
  • 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: 3M New Zealand Ltd, 250 Archers Road, Glenfield, AUCKLAND 0627
  • Reason
    The manufacturer has received higher than anticipated reports of lava ultimate debonding when used for dental crowns. the manufacturer is removing use with dental crowns from the indications for use.
  • Action
    Instructions for use to be updated

Device

3M Lava Ultimate CAD/CAM Restorative

Manufacturer

3M ESPE Dental Products
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    NZMMDSA