Events

Retiro De Equipo (Recall) de Trinity Acetabular Shell

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Corin 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-2016-RN-00131-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-02-10
  • 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-2016-RN-00131-1
  • 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
    There is potential for abrasion of the sterile barrier pouches of the new packaging system which was introduced in november 2015. if this failure was to occur, it could potentially render the product non-sterile.There have been no product complaints received about this issue to date.
  • Acción
    Corin is advising users to return all affected product. Product will be replaced with stock packaged in the previous packaging system.

Device

Trinity Acetabular Shell
  • Modelo / Serial
    Trinity Acetabular ShellMultiple Part Numbers affectedMultiple Lot Codes affectedARTG Number: 235377
  • Manufacturer
    Corin Australia Pty Ltd

Manufacturer

Corin Australia Pty Ltd