Events

Recall of Premise Universal Restorative Body Syringe and Unidose, Shade A2 (Dental restorative material to fill cavities)

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-2014-RN-01015-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-09-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01015-1
  • 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
    Kerr australia has received some complaints that the premise a2 composite are sticky and difficult to use.. please note that there are no safety issues associated with using this product.
  • Action
    End users are advised that if they have any of the affected product in their inventory to immediately return it to Kerr Australia. This action has been closed-out on 29/02/2016.

Device

Premise Universal Restorative Body Syringe and Unidose, Shade A2 (Dental restorative material to ...
  • Model / Serial
    Premise Universal Restorative Body Syringe and Unidose, Shade A2 (Dental restorative material to fill cavities)REFILL - SYRINGE PREMISE A2 (4g)Part Number: 32618Lot Numbers: 4941320, 4946443, 4906963REFILL - UNIDOSE PREMISE A2 (20 tips 0.2g each = 4g)Part Number: 32651Lot Numbers: 4908202, 4890805, 4890804, 4890806, 4946447
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd