Recall of 3M ESPE Filtek Supreme XTE Flowable Restorative (Dental material)

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 III
  • 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
    Two lots of 3m espe filtek supreme xte flowable restorative (ginseng) have been mislabelled. product labelled a2 shade contains a3.5 shade restorative material, and product labelled a3.5 contains a2 shade restorative material. 3m australia has advised that there is no health or safety hazard associated with this product.
  • Action
    3M is requesting its customers to place the product on hold and return any affected product.


  • Model / Serial
    3M ESPE Filtek Supreme XTE Flowable Restorative (Dental material)Product Code 4920A2 (Shade A2): Lot # N522403Product Code 4920A3.5 (Shade A3.5): Lot # N536129ARTG Number: 149476
  • Manufacturer


  • Manufacturer Parent Company (2017)
  • Source