Events

Recall of TempSpan CMT (Temporary composite 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-01002-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-09-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01002-1
  • 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
    The current directions for use for tempspan cmt lists a working time that is not indicative of the actual performance of the product. the current directions for use lists the total working time as 60 seconds, whereas the minimum working time is 45 seconds.
  • Action
    Updating the directions for use.

Device

TempSpan CMT (Temporary composite dental cement)
  • Model / Serial
    TempSpan CMT (Temporary composite dental cement)Part Number: N69CAAll lot numbers are affectedARTG Number: 171468
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd