Events

Retiro De Equipo (Recall) de Vanguard Open Box Femoral Components

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Zimmer Biomet 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-2017-RN-00055-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-01-18
  • 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-2017-RN-00055-1
  • 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
    As a result of inadequate line clearance between the 5th april 2016 and the 1st september 2016, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). the estimated rate of occurrence is 0.001% (<1 in 1000 products). it is highly detectable at the point of use that the device has been incorrectly labelled. at this stage, no complaints have been received for this issue.
  • Acción
    Zimmer Biomet is advising surgeons to monitor patients through regular consultations to determine the need for any treatment. This action has been closed-out on 18/05/2017.

Device

Vanguard Open Box Femoral Components
  • Modelo / Serial
    Vanguard Open Box Femoral ComponentsVAN PS OPEN INTL FEM-RT 62.5Item Number: 183106Lot Number: J3849157VAN PS OPEN INTL FEM-RT 65Item Number: 183108Lot Number: J3767826VAN PS OPEN INTL FEM-LT 62.5Item Number: 183126Lot Number: J3844467VAN PS OPEN INTL FEM-LT 65Item Number: 183128Lot Number: J3838223VAN PS OPEN INTL FEM-LT 67.5Item Number: 183130Lot Number: J3778437ARTG Number: 218510
  • Manufacturer
    Zimmer Biomet Pty Ltd

Manufacturer

Zimmer Biomet 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