Events

Retiro De Equipo (Recall) de Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules

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
    Recall
  • ID del evento
    RC-2014-RN-00606-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-03
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00606-1
  • 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
    The manufacturer, kerr corporation has received complaints that the amalgam may set faster than specified in the directions for use. this set time discrepancy may cause the product to set before there is an opportunity to place it in the preparation or to complete the carving process. there is a low risk associated with the use of this product in that there would be a possible need to remove the set amalgam from the preparation and repeat the procedure.
  • Acción
    Customers are advised to immediately return any of the affected stock to Kerr Australia for replacement with unaffected stock.

Device

Tytin Regular Set (Dental amalgam) Tytin Regular Set, Double Spill - 50 Capsules
  • Modelo / Serial
    Tytin Regular Set (Dental amalgam)Tytin Regular Set, Double Spill - 50 CapsulesPart number: 29948Lot number: 3-1249ARTG Number: 99936
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd