Events

Retiro De Equipo (Recall) de 3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants

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-2014-RN-01222-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-02
  • 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-01222-1
  • 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
    Biomet 3i has identified a visually observable condition which may be present on a limited number of the identified implants. the condition is caused by the implant coming into contact with residual machining fluid which was not adequately degreased from a portion of 1 lot of packaging cylinders. the residual machining fluid causes the implants to be discoloured. biomet 3i has determined that there are no known health effects of the residue. this has been confirmed through cytotoxicity and endotoxicity tests, which have yielded negative results for toxins on residue-affected samples.
  • Acción
    No affected units are known to have been implanted in Australia. Customers are advised to return affected products to BIOMET 3i Australia Pty Ltd for replacement with unaffected units. This action has been closed-out on 14/07/2016.

Device

3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants
  • Modelo / Serial
    3i T3, Full Osseotite Tapered & Parallel Walled Dental Implants3i T3 Non-Platform Switched Tapered Implant 3.25X8.5 -15.0mmCatalog Number BOST3211Lot Numbers: 2014051395 (Expiry: 12/11/2018), 2014051817 (Expiry: 12/09/2018)Full Osseotite Certain Implant 3.25X8.5 - 15.0mmCatalog Number XIFNT3211 Lot Number 2014051477 (Expiry: 12/06/2018)Parallel Walled Certain 2 Implant 3.25X8.5 - 18mmCatalog Number: XIFOSM311Lot Number: 2014051368 (Expiry: 12/03/2018)ARTG Number100482
  • 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