Events

Safety Alert for Dental implant machine

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by MP Manufacturer Unknown Sender: Sofine Group Co., Ltd., 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
    12
  • Date
    2015-04-30
  • 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
    Neither the medical device nor the instructions for use indicate the ce conformity marking; there is no information on the manufacturer on the medical device or on its packaging; neither the medical device nor the packaging nor the instructions for use contain data on the manufacturer's authorized representative in the european economic area; the batch / serial number is not specified on the medical device. the manufacturer's address is not specified in the operating instructions.
  • Action
    Disallowed to market

Device

Dental implant machine

Manufacturer

MP Manufacturer Unknown Sender: Sofine Group Co., Ltd., China
  • Manufacturers representative
    UAB RA DENTAL
  • Source
    MH