Events

Safety Alert for Orthodontic Wires (Niti Archwires)

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by United Dental, China.

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
    16
  • Date
    2015-05-26
  • 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 individual packaging of medical devices bears the ce conformity marking, but does not have a notified body number; there is no manufacturer's address, no data on an authorized representative in the european economic area. no information is available on the safe use of the medical device.
  • Action
    Disallowed to market

Device

Orthodontic Wires (Niti Archwires)

Manufacturer

United Dental, China
  • Manufacturers representative
    IĮ Aesthetic Odontology Center
  • Source
    MH