Recall of 3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M Australia 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Approximately 10% of users globally have reported to 3m that lava ultimate crowns de-bonded at a rate higher than their typical experience for crowns. the reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
  • Action
    3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016.


  • Model / Serial
    3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)ARTG Number: 191737
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source