Events

Safety Alert for Orthopedic devices for the treatment of fractures

According to Ministry of Health, this safety alert involved a device in Lithuania that was produced by Vigor Ortho, India.

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
    1
  • Date
    2018-04-06
  • 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 orthopedic screws in the bundle are packed in plastic bags with a label affixed to them. no additional information on these propellers or their use has been added to the packaging. the label shows the manufacturer of the medical device: vigor ortho (india) but does not specify the manufacturer's authorized representative in the european community (does not meet the requirement of annex 1, paragraph 14.3.1 of the regulation); the label states that the medical device is placed on the market non-sterile but does not provide information on how this medical device should be sterilized before its intended use (implantation) (does not meet the requirement of annex 1, paragraph 14.3.10 of the regulation); eudamed, the european database for medical devices, has no information on the manufacturer vigor ortho (india), and there is no information that this manufacturer will be issued with a certificate of compliance with the requirements of the council directive 93/42 / eec on medical devices. commodities are ce marked with the number of the notified body 2107. the list of notified bodies of existing medical devices published by the european commission in the notified bodies of the european commission does not include the notified body number 2107 (does not meet the requirements of article 40 of the regulation).
  • Action
    Do not allow to enter the Lithuanian market

Device

Orthopedic devices for the treatment of fractures

Manufacturer

Vigor Ortho, India
  • Manufacturers representative
    JSC Gameda
  • Source
    MH