Events

Alerte De Sécurité sur 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par 3M ESPE Dental Products.

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
  • Date
    2013-12-04
  • Date de publication de l'événement
    2013-12-04
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20131204.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: 3m espe imprint ii regular body vps impression material refill medical device manufacturer, 3m espe dental products, has issued a medical device safety alert concerning its imprint ii regular body vps impression material refill 4-pack [catalogue number: 9379; lot number: n510884 and n510889]. the manufacturer is conducting a voluntary recall of the above affected products. the reason for the recall of this product is that the moisture displacement feature is greatly reduced, which may impact the quality of a dental impression. the manufacturer will arrange for return and replacement of affected products. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 december 2013.

Device

3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: 3M ESPE IMPRINT II Regular Body VPS Impression Material Refill
  • Manufacturer
    3M ESPE Dental Products

Manufacturer

3M ESPE Dental Products