Events

Retiro De Equipo (Recall) de SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Implant Direct Oceania 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-2018-RN-00064-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-01-29
  • 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-2018-RN-00064-1
  • 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
    Implant direct, through their regulatory affairs reporting process, have found that the extender that is packaged with the swishtapered implant have been packaged in the incorrect position (upside down in the plastic retainer). this discrepancy may lead to the possibility of the extender not seating properly in the implant.No reports of injury have been received to date.
  • Acción
    Implant Direct is advising users to return any affected product.

Device

SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD Platform
  • Modelo / Serial
    SwishTapered Implant 4.1mmD x12mmL SBM Dual Blast; 4.8mmD PlatformPart Numbers: 934112Kit/Refill/Syringe Lot Number: 69101Expiry date: 1 October 2020ARTG Number: 238870
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA