Recall of Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Kerr 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
    Recall
  • Event ID
    RC-2016-RN-00770-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2016-06-08
  • Event Country
  • Event Source
    DHTGA
  • 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
    Kerr australia is recalling certain lots of herculite ultra, herculite xrv, point 4, and premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. the particulate is unlikely to cause any adverse health consequences.
  • Action
    Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.

Device

  • Model / Serial
    Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)Multiple Lot Numbers and Part Numbers affectedShipped between June 2015 and April 2016ARTG Number: 99818
  • Manufacturer

Manufacturer