Retiro De Equipo (Recall) de Sealapex Xpress(calcium hydroxide polymeric root canal sealant)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Kerr Australia Pty 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    A labelling error has been identified with a single lot of sealapex xpress. the product’s syringe label correctly identifies the expiration date as 2016-11. some carton labels incorrectly identify the expiration date as 2017-11. product used past the correct expiration date of 2016-11 may not perform as intended. such product may exhibit crystals in the catalyst paste.
  • Acción
    Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.


  • Modelo / Serial
    Sealapex Xpress(calcium hydroxide polymeric root canal sealant)Part Number: 33639Lot Number: 5-1310ARTG Number: 236668
  • Manufacturer