Events

Retiro De Equipo (Recall) de 50mm Left Standard Ti Mandible(Titanium Mandible 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 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-01132-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-20
  • 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-01132-1
  • 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 microfixation has initiated this action following an internal investigation which identified that the titanium mandible implants may exhibit fatigue fracture due to a laser etch that was delivered at a more powerful setting resulting in a wider and deeper etch. the laser is used to etch the part number, lot number, and logo on the implant.
  • Acción
    Biomet Australia is notifying surgeons and hospitals of the potential problem and providing instructions for clinical follow up. Further information can be found on the TGA website. This action has been closed-out on 06/06/2016.

Device

50mm Left Standard Ti Mandible(Titanium Mandible Implants)
  • Modelo / Serial
    50mm Left Standard Ti Mandible(Titanium Mandible Implants)Item Reference : 24-6551TIBatch numbers: 525190A & 525190B ARTG Number: 145265
  • Manufacturer
    Biomet Australia Pty Ltd

Manufacturer

Biomet 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