Events

Recall of Alginot (dental impression material); AlgiNot Cartridge Intro Kit; AlgiNot Cartridge Refill; AlgiNot Sample Pack; AlgiNot FS Cartridge Intro Kit; AlgiNot FS Cartridge Refill; AlgiNot FS Sample Pack; AlgiNot Volume Refill; AlgiNot Volume Intro Kit; AlgiNot FS Volume Refill; AlgiNot FS Volume Intro Kit

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ormco 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-00674-3
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-07-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00674-3
  • 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
    The current instructions for use (ifu's) for alginot include product specifications and instructions that are not indicative of the actual performance of the product. more specifically, the ifu's incorrectly state the work time/mouth removal time.
  • Action
    Kerr Australia is providing updated Instructions for Use (IFU)

Device

Alginot (dental impression material); AlgiNot Cartridge Intro Kit; AlgiNot Cartridge Refill; Algi...
  • Model / Serial
    Alginot (dental impression material); All product lots within shelf lifeAlgiNot Cartridge Intro Kit; Part No. 33034AlgiNot Cartridge Refill; Part No. 33035AlgiNot Sample Pack; Part No. 33141AlgiNot FS Cartridge Intro Kit; Part No. 33816AlgiNot FS Cartridge Refill; Part No. 33817AlgiNot FS Sample Pack; Part No. 33848AlgiNot Volume Refill; part No. 34680AlgiNot Volume Intro Kit; Part No. 34681AlgiNot FS Volume Refill; Part No. 34682AlgiNot FS Volume Intro Kit; Part No. 34683
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd