Events

Retiro De Equipo (Recall) de PROFILE VORTEX ROTARY FILES

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por DENTSPLY CANADA LTD..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    57221
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-07-07
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    As per health hazard evaluation (hhe-309) the risk is level iii as the health consequence is such that it requires or has the potential to require medical or surgical intervention. there is no long-term health impact on teh patient. also additional/unplanned internventions or corrections during the course of a treatment or after a treatment with no health risk to the patient could be experienced. the use of a larger dimension instrument can adversely affect the ability to complete endodontic treatments.

Device

PROFILE VORTEX ROTARY FILES
  • Modelo / Serial
    Model Catalog: PFV042021 (Lot serial: 0000116559); Model Catalog: PFV043521 (Lot serial: 0000116559); Model Catalog: PFV042021 (Lot serial: 0000117309); Model Catalog: PFV043521 (Lot serial: 0000117309)
  • Descripción del producto
    Profile Vortex rotary files
  • Manufacturer
    DENTSPLY CANADA LTD.

Manufacturer

DENTSPLY CANADA LTD.