Events

Safety Alert for Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L (3D-23G-90mm), COG PDO Tread Blunt (3DB19G-100mm), 3D COG Thread Sharp (3D-22G70mm)

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
    6
  • Date
    2017-11-24
  • 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 devices are marked with two ce conformity marks with the number of the notified bodies 1282 and 0197. in accordance with the provisions of the regulation, the ce marking must be accompanied by the identification number of one of the notified bodies responsible for applying the procedures set out in the annexes to this regulation. in addition, the ce mark does not conform to the form set out in annex 12 to the regulation. such marking does not comply with the requirements of articles 38-40 of the regulation; instructions for use have not been added to medical devices as required by annex 1, paragraph 14.1 of the regulation; medical devices do not include the name and address of the manufacturer and the authorized representative within the european union and its address as required by annex 1, paragraph 14.3.1 of the regulation.
  • Action
    Not allowed to enter the Lithuanian market

Device

Sterile Thread for Face Correction PDO Thread (Absorbable Polydioxanone Suture): 3D COG Thread L ...

Manufacturer

Not specified
  • Manufacturers representative
    UAB Urmo Group
  • Source
    MH