Events

Alerte De Sécurité sur TF Adaptive Gutta Percha Point Size SM3-50pk

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Ormco Corporation.

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
    2016-02-18
  • Date de publication de l'événement
    2016-02-18
  • 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_20160218a.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: ormco corporation tf adaptive gutta percha point size sm3-50pk medical device manufacturer, ormco corporation, has issued a medical device safety alert concerning its tf adaptive gutta percha point size sm3-50pk. [part number: 815-1541; lot number: ge15011637]. the manufacturer has become aware of a mismatch of the above product’s inner and outer labels. the outer package of the product is identified as sm3, which matches the product inside. however, the inner generic label is identified as ml3. according to the manufacturer, this product would be used correctly in a properly obturated canal. if a doctor removed the cover of the tray and is only looking at the inner label, he could mistakenly use the sm gutta percha with a ml file system. this sm3 gp will not properly fill the canal due to smaller size and can result in the gutta percha slipping past the apex of the root. product recall is on-going. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2016.

Device

TF Adaptive Gutta Percha Point Size SM3-50pk
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Ormco Corporation TF Adaptive Gutta Percha Point Size SM3-50pk
  • Manufacturer
    Ormco Corporation

Manufacturer

Ormco Corporation