Events

Retiro De Equipo (Recall) de Kerr Herculite Ultra Composite Restoratives

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 Kerr Corporation.

¿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
    17206
  • Fecha de inicio del evento
    2014-08-28
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: Henry Schein New Zealand, 23 William Pickering Drive, Albany, North Shore City, Auckland
  • Causa
    The manufacturer has received complaints that the herculite ultra product may be difficult to extrude or may not perform as intended. investigation of the retained and returned product confirmed that the composite does not extrude easily. additionally, any composite extruded was determined to exhibit signs of dryness and was not workable upon manipulation.
  • Acción
    Product to be returned to supplier

Device

Kerr Herculite Ultra Composite Restoratives
  • Modelo / Serial
    Model: Part Numbers: 35166, 34348, 34448, 34338, Affected: Specific lots
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation