Safety Alert for 30mm LSX files

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
    2012-12-11
  • Event Date Posted
    2012-12-11
  • Event Country
  • Event Source
    DH
  • Event Source URL
  • 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
    Medical device safety alert: sybron dental 30mm lsx files medical device manufacturer, sybron dental specialties, inc., has initiateda field corrective action concerningthe lsx files. the manufacturer found that packages of 30mm lsx files were mispackaged as 25mm lsx files.There are no safety or efficacy issues associated with this problem. according to the manufacturer, 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. posted on 11 december 2012.

Device

  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Sybron Dental 30mm LSX files
  • Manufacturer

Manufacturer