Events

Alerte De Sécurité sur Orthopedic devices for the treatment of fractures

Selon Ministry of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Lithuania qui a été fabriqué par Vigor Ortho, India.

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
    1
  • Date
    2018-04-06
  • 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
    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
  • Représentant du fabricant
    JSC Gameda
  • Source
    MH