Events

Recall of Maxcem Elite (Dental cement)

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-2013-RN-00198-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00198-1
  • 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
    It has come to the attention of kerr australia that an issue with the raw material used to produce the affected lots of maxcem elite causes the material to prematurely polymerise in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to replacing restorations on the tooth or core build up. as a result, the restoration may not be sealed properly.
  • Action
    Kerr Australia is requesting customers to review their stock and to determine if they have any affected lots. Any affected lots have been requested to be returned to Kerr Australia immediately.

Device

Maxcem Elite (Dental cement)
  • Model / Serial
    Maxcem Elite (Dental cement)Multiple part numbers and lot numbersProduct with expiration dates through August 2015ARTG Number: 175450
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd