Events

Retiro De Equipo (Recall) de Various ZNN & M/DN Guide Wires

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-2018-RN-00510-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-05-23
  • 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-00510-1
  • 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 specific lots of znn and m/dn trauma guide wires may exhibit process monitoring failures related to the sterile seal on the packaging. a breach in the packaging seal could potentially lead to loss of sterility of the device.To date, no complaints have been reported as a result of this issue.
  • Acción
    Zimmer Biomet is advising customers to identify and quarantine affected stock as necessary. Zimmer Biomet will contact users to remove any identified affected product and provide replacement.

Device

Various ZNN & M/DN Guide Wires
  • Modelo / Serial
    Various ZNN & M/DN Guide WiresItem Numbers: 00-2228-024-00, 47-2237-037-00, 47-2237-038-00, 47-2255-008-00, 47-2255-008-01, 47-2490-097-00 and 47-2490-098-00Multiple Products and Lot NumbersARTG Numbers: 118540 and 112735
  • 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