Events

Recall of Tytin – Regular Set, Double Spill 50 and 500 capsules (self activating capsules of dental alloy used as a dental restorative)

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-00104-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-01-29
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00104-1
  • 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
    It was discovered that the product may set 15 seconds 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 tooth cavity.
  • Action
    Kerr is requesting users return affected stock for replacement or credit. This action has been closed-out on 11/02/2016.

Device

Tytin – Regular Set, Double Spill 50 and 500 capsules (self activating capsules of dental alloy u...
  • Model / Serial
    Tytin – Regular Set, Double Spill 50 and 500 capsules (self activating capsules of dental alloy used as a dental restorative)Tytin – Regular Set, Double Spill – 500 capsulesPart Number: 29949Tytin – Regular Set, Double Spill – 50 capsulesPart Number:29948Lot Number: 3-1069ARTG Number: 99936
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd