Events

Recall of Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules

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-00606-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00606-1
  • 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 manufacturer, kerr corporation has received complaints that the amalgam may set faster than specified in the directions for use. this set time discrepancy may cause the product to set before there is an opportunity to place it in the preparation or to complete the carving process. there is a low risk associated with the use of this product in that there would be a possible need to remove the set amalgam from the preparation and repeat the procedure.
  • Action
    Customers are advised to immediately return any of the affected stock to Kerr Australia for replacement with unaffected stock.

Device

Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules
  • Model / Serial
    Tytin Regular Set (Dental amalgam)Tytin Regular Set, Double Spill - 50 CapsulesPart number: 29948Lot number: 3-1249ARTG Number: 99936
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd