Events

Retiro De Equipo (Recall) de Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves

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-2018-RN-00509-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-21
  • 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-00509-1
  • 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
    Zimmer biomet has identified a single lot of tapered screw-vent implants that were inadvertently packaged with patient chart labels which incorrectly indicate tsvb10 lot number 63773888. all outer and inner labels are correct.
  • Acción
    For unused product, Zimmer Biomet is advising customers to return affected product. For implanted devices, Zimmer is advising customers to update patient records with the correct part and lot number.

Device

Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and Microgrooves
  • Modelo / Serial
    Tapered Screw-Vent Implants with 0.5 mm Machined Collar, MTX Surface and MicrogroovesPart Number: TSVM4B10Lot Number: 63781164ARTG Number: 126088
  • 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