Events

Safety Alert for orthopedic screws, orthopedic screwdriver and hip plate

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
    2017-05-29
  • 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 and labels do not bear the ce conformity marking and the number of the notified body (not in compliance with points 38, 39 and 40 of the regulation); there are no instructions for use attached to medical devices (not in compliance with clause 14.1 of annex 1 to the regulation); the medical device labels do not contain information on the manufacturer's authorized representative in the european economic area (not in compliance with annex 1, paragraph 14.3.1 of the regulation); method of sterilization of medical devices not indicated on the labels of medical devices (does not comply with point 14.3.10 of annex 1 to the regulation); the batch number of 135 ° on the hip plate with 3 holes (not in accordance with annex 1, paragraph 14.5 of the regulation); labeled by vigor ortho (india). after checking the information in the eudamed, such a manufacturer is not registered.
  • Action
    Not allowed to enter the Lithuanian market

Device

orthopedic screws, orthopedic screwdriver and hip plate

Manufacturer

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