Events

Safety Alert for Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBoneScrew)

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
    5
  • Date
    2017-12-01
  • 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
    Manufacturer and its authorized representative in the european economic area not indicated on the label of the medical device and on the outer packaging and the address is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); packages of medical devices are not marked with the ce conformity marking and the number of the notified body (not in accordance with the requirements of points 38 and 40 of the regulation); the medical device label is marked with the symbol "see instructions for use", but the instructions for use are not included (does not meet the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not contain the information necessary to identify the medical device and the contents of the packaging (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); the expiry date of the medical device labels is "2017-0919". in view of this, the period of validity (fitness for use) of medical devices has expired and can no longer be used.
  • Action
    Do not allow to enter the Lithuanian market

Device

Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBone...

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH