Events

Alerta De Seguridad para Dental Implants (Polymer Discs for Dental Crowns, Bridges, Dentures)

Según Ministry of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Lithuania que fue producido por Not specified.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Número del evento
    4
  • Fecha
    2018-04-25
  • País del evento
    Lithuania
  • Fuente del evento
    MH
  • URL de la fuente del evento
    http://www.vaspvt.gov.lt/node/115
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    The medical equipment contained in the batch is packed individually in one piece of paper in a single box with a total of 5 boxes. all boxes are placed in a paper transport envelope; all boxes and discs do not include the manufacturer's name, address and manufacturer's authorized representative in the european economic area (not in compliance with the requirement of annex 1, paragraph 14.3.1 of the regulation); all boxes and discs do not bear the ce conformity marking and the notified body number (not in accordance with the requirements of articles 38, 39 and 40 of the regulation); the three packages do not contain information identifying the contents of the package (does not meet the requirements of article 14.3.2 of the regulation); no batch / serial number on the two packages marked peek dental disc (does not meet the requirements of annex 1, paragraph 14.3.4 of the regulation).
  • Acción
    Do not allow to enter the Lithuanian market

Device

Dental Implants (Polymer Discs for Dental Crowns, Bridges, Dentures)

Manufacturer

Not specified
  • Representante del fabricante
    UAB Urmo Group
  • Source
    MH