Events

Alerta De Seguridad para Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBoneScrew)

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
    5
  • Fecha
    2017-12-01
  • 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
    Manufacturer and its authorized representative in the european economic area not indicated on the label of the medical device and on the outer packaging and the address is not specified (does not meet the requirements of annex 1, paragraph 14.3.1 of the regulation); packages of medical devices are not marked with the ce conformity marking and the number of the notified body (not in accordance with the requirements of points 38 and 40 of the regulation); the medical device label is marked with the symbol "see instructions for use", but the instructions for use are not included (does not meet the requirements of annex 1, paragraph 14.1 of the regulation); medical device labels do not contain the information necessary to identify the medical device and the contents of the packaging (not in compliance with the requirements of annex 1, paragraph 14.3.2 of the regulation); the expiry date of the medical device labels is "2017-0919". in view of this, the period of validity (fitness for use) of medical devices has expired and can no longer be used.
  • Acción
    Do not allow to enter the Lithuanian market

Device

Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBone...

Manufacturer

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