Events

Recall of TempBond NE (temporary 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-2012-RN-00809-3
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-08-09
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00809-3
  • 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 advises that the current directions for use for tempbond ne lists a working time that is not indicative of the actual performance of the product. more specifically, the current directions for use lists the total working time as 90 seconds, while the material actually provides a minimum working time of 60 seconds.
  • Action
    Kerr Australia is providing updated Instructions for Use (IFU)

Device

TempBond NE (temporary dental cement)
  • Model / Serial
    TempBond NE (temporary dental cement)Part Number: 33217 - 5ml SyringeAll lots within shelf lifeARTG Number: 171468
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd