Retiro De Equipo (Recall) de Dentsply Fluorocore 2+ Fast Set

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Dentsply Caulk.

¿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
    15031
  • Fecha de inicio del evento
    2013-07-24
  • País del evento
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Dentsply Sirona (NZ) Limited, C/- Lowndes Jordan, Level 15, PWC Tower, 188 Quay Street, Auckland 1010
  • Causa
    Manufacturer have advised that two lots (batches) of fluorocore may exhibit faster setting characteristics than is normal for these products. while it has ben determined that there is no health risk to either patients or dental professionals associated with these products, the identified lot numbers do not meet the manufacturer's standards for product quality.
  • Acción
    Product to be returned to supplier

Device

  • Modelo / Serial
    Model: 612402, Affected: 1209242 and 120904
  • Manufacturer

Manufacturer