Events

Recall of Sealapex Xpress(calcium hydroxide polymeric root canal sealant)

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-2017-RN-00314-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00314-1
  • 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
    A labelling error has been identified with a single lot of sealapex xpress. the product’s syringe label correctly identifies the expiration date as 2016-11. some carton labels incorrectly identify the expiration date as 2017-11. product used past the correct expiration date of 2016-11 may not perform as intended. such product may exhibit crystals in the catalyst paste.
  • Action
    Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.

Device

Sealapex Xpress(calcium hydroxide polymeric root canal sealant)
  • Model / Serial
    Sealapex Xpress(calcium hydroxide polymeric root canal sealant)Part Number: 33639Lot Number: 5-1310ARTG Number: 236668
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd