Events

Alerte De Sécurité sur Dental Microimplant Bomei and Dental Microimplant and their Thread Tool Newton's A (OrthoBoneScrew)

Selon Ministry of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Lithuania qui a été fabriqué par Not specified.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Numéro de l'événement
    5
  • Date
    2017-12-01
  • Pays de l'événement
    Lithuania
  • Source de l'événement
    MH
  • URL de la source de l'événement
    http://www.vaspvt.gov.lt/node/115
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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
  • Représentant du fabricant
    UAB Urmo Group
  • Source
    MH