Events

Retiro De Equipo (Recall) de Vanguard Open Box Posterior Stabilised 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-00984-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-10
  • 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-00984-1
  • 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 an issue with vanguard open box posterior stabilised femoral components where inadequate line clearance at the supplier between 5 april 2016 and 1 september 2016. as a result, the packaging of some femoral components was incorrectly labelled as either smaller or larger and/or as the incorrect side (right/left). it is highly detectable at the point of use that the device was incorrectly labelled. the estimated rate of occurrence is <1 in 1,000 products.
  • Acción
    Zimmer is requesting surgeons: 1. Review the notification and ensure affected personnel are aware of the contents; 2. Complete the Certificate of Acknowledgement supplied with the customer letter, then a. Return a copy to RAQA.ANZ@zimmerbiomet.com; and b. Retain a copy of the Acknowledgement Form with your field action records in the event of a compliance audit of your facilities documentation. 3. If after reviewing this notice there are further questions or concerns please contact the local Zimmer Biomet representative.

Device

Vanguard Open Box Posterior Stabilised Femoral Components
  • Modelo / Serial
    Vanguard Open Box Posterior Stabilised Femoral ComponentsItem Number :183106Lot Number: J3842173Item Number: 183106Lot Number: J3844489ARTG 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