Events

Retiro De Equipo (Recall) de Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expiration dates between November 2015 and November 2020.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Biomet 3i 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-2015-RN-01208-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-12-09
  • 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-2015-RN-01208-1
  • 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
    An investigation has determined that a limited number of product pouches may not have been sealed during packaging (occurrence rate 0.008%). in the event that a product pouch is unsealed, the sterility of the product contained within the pouch cannot be assured and may lead to infections or the product may be missing.
  • Acción
    The sponsor is advising users to inspect stock and quarantine units from the affected lots regardless of whether a packaging seal can be visualised prior to their return to the sponsor. This action has been closed-out on 29/08/2016.

Device

Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expir...
  • Modelo / Serial
    Multiple dental abutment products and their accessories.Multiple Item Numbers affected with expiration dates between November 2015 and November 2020.ARTG: 120288
  • Manufacturer
    Biomet 3i Australia Pty Ltd

Manufacturer

Biomet 3i Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    DHTGA