Events

Safety Alert for Dental Implant Fasteners - Abutment + screw

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
    2
  • Date
    2018-02-18
  • 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
    Medical devices are not affixed with the ce marking and the number of the notified body (not in accordance with the requirements of articles 38, 39 and 40 of the regulation); the label of the medical device does not contain information on the manufacturer and the manufacturer's authorized representative in the european economic area (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); medical device labels do not contain the information necessary to identify the medical device and the contents of the package (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); no batch / serial number of the medical device (does not meet the requirement of annex 1, paragraph 14.3.4 of the regulation); conditions for the storage and maintenance of the special medical device, special conditions of use and warnings and precautions (not in compliance with the requirements of 14.3.9, 14.3.10, 14.3.11 of annex 1 to the regulation) are not specified.
  • Action
    Do not allow to enter the Lithuanian market

Device

Dental Implant Fasteners - Abutment + screw

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH