Events

Recall of TempSpan CMT Dental Cement (used to take dental impressions)

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-00024-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-01-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00024-1
  • 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 advises that these products may exhibit work time fluctuations and work faster than what the directions for use advises.
  • Action
    Kerr Australia has requested that dentists and distributors return all lots of TempSpan CMT, Part numbers N69CA and N69CS. Distributors are requested to ensure that any customer they have supplied the product is identified and notified of the the recall within 48 hours.

Device

TempSpan CMT Dental Cement (used to take dental impressions)
  • Model / Serial
    TempSpan CMT Dental Cement (used to take dental impressions)Part numbers: N69CA and N69CSAll lot numbers are affectedARTG Number: 171468
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd