Events

Safety Alert for K3 Gutta Percha

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Sybron Dental Specialties.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2012-02-23
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120223b.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Field safety notice: sybronendo k3 gutta percha medical device manufacturer, sybron dental specialties, inc., has issued a field safety notice concerning the recall of one lot of k3 gutta percha. the manufacturer found that one lot of k3 gutta percha box labeled as part number 825-0625, which is the red-band #25 tip gutta percha, actually contain blue-band #30 tip gutta percha (part number 825-0630). according to the manufacturer, the product will function as expected and there are no safety or efficacy issues. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

K3 Gutta Percha
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: SybronEndo K3 Gutta Percha
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties