Events

Recall of NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation)

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-00983-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00983-1
  • 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
    Nx3 try-in gels allow for the restorations to be seated temporarily for review of their final appearance prior to cementation. kerr australia have received reports that some nx3 try-in gel syringes in the affected lot incorrectly contain a polishing paste. as the material in the affected syringe does not match the shade of the cement as it is labeled there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration colour requiring the need to remove and repeat the restoration.
  • Action
    Kerr Australia is requesting customers to stop using the affected product and return to Kerr Australia for replacement or credit.

Device

NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a t...
  • Model / Serial
    NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation)Part Number: 33660Syringe Lot Number: 4580333Autobag Lot Number: 4584609Expiry date: February 2014ARTG Number: 176398
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd