Events

Alerte De Sécurité sur TempSpan CMT

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

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
    2013-01-23
  • Date de publication de l'événement
    2013-01-23
  • 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_20130123.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: sybron dental specialties tempspan cmt medical device manufacturer, sybron dental specialties, inc., has issued a customer notification concerning all production lots within shelf life of tempspan cmt. the affected part numbers are n69ca and n69cs. the manufacturer is conducting a voluntary recall of tempspan cmt production lots that were shipped to customers since january 2011 because they may exhibit work time fluctuations and work faster than what the dfu advises. although there are no safety or efficacy issues associated with this product according to the manufacturer, product recall is ongoing. according to the manufacturer, the affected products were distributed in hong kong. if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 23 january 2013.

Device

TempSpan CMT
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Sybron Dental Specialties TempSpan CMT
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties