Events

Safety Alert for Endodontic broken file removal system

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Not specified.

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
  • Event Number
    4
  • Date
    2017-11-14
  • Event Country
    Lithuania
  • Event Source
    MH
  • Event Source URL
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alerts
    Data from Lithuania is current through December 2018. All of the data comes from the Ministry of Health, 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 Lithuania.
  • Extra notes in the data
  • Reason
    The medical device does not bear the ce marking as required by articles 38-40 of the regulation; no instructions for use added to the medical device as required by annex 1, paragraph 14.1 of the regulation; the name and address of the manufacturer and the authorized representative in the european union and its address, as required by point 14.3.1 of annex 1 to the regulation; no specific medical device maintenance, use conditions and warnings and / or precautionary measures, as required by 14.3.9-14.3.12 of annex 1 to the regulation.
  • Action
    Do not allow to enter the Lithuanian market

Device

Endodontic broken file removal system

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH