Events

Recall of Fill-In Refill A1 and A2 (temporary crown/bridge)

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-2012-RN-01291-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-12-24
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01291-1
  • 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
    This product may set faster than indicated in the directions for use. although an inconvenience, there are no safety or efficacy issues associated with material, as the product will set.
  • Action
    Kerr Australia is asking customers to return the affected stock.

Device

Fill-In Refill A1 and A2 (temporary crown/bridge)
  • Model / Serial
    Fill-In Refill A1 and A2 (temporary crown/bridge)Fill-In - Refill A1Part number: 32491Lot number: 3775866Fill-In - Refill A2Part number: 32492Lot number: 4285057ARTG Number: 175451
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd