Events

Alerta De Seguridad O Notificaciones De Seguridad para Various trauma guide wires

Según Medicines and Healthcare products Regulatory Agency, este evento ( alerta de seguridad o notificaciones de seguridad ) involucró a un dispositivo médico en United Kingdom que fue producido por Zimmer Biomet.

¿Qué es esto?

Las notificaciones de seguridad de campo son comunicaciones sobre acciones que se pueden estar tomando en relación con un producto que se encuentra en el mercado, enviadas por los fabricantes de dispositivos médicos o sus representantes. Estas notificaciones son principalmente para trabajadores de la salud, pero también para usuarios. Pueden incluir alertas y retiro de equipos.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert / Field Safety Notice
  • Fecha
    2018-09-24
  • Fecha de publicación del evento
    2018-09-24
  • País del evento
    United Kingdom
  • Fuente del evento
    MHRA
  • URL de la fuente del evento
    https://www.gov.uk//drug-device-alerts/various-trauma-guide-wires-risk-of-infection-due-to-packaging-failure-mda-2018-032
  • Notas / Alertas
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Notas adicionales en la data
  • Causa
    Manufactured by zimmer biomet with expiry dates prior to 31 may 2028 – wire may breach packaging, compromising sterility of device.
  • Acción
    Locate, quarantine and return all affected product. Return acknowledgement document to manufacturer (or complete online form as stated in the Field Safety Notice (FSN)).

Device

Various trauma guide wires
  • Modelo / Serial
  • Descripción del producto
    Affected devices with expiry date prior to 31 May 2028:Item Number Item Description 469360 green 469340 yellow 469320 green 469060 yellow 469055 green 469040 yellow 469020 green 467265 yellow 467260 green 467220 yellow 29402 green 14-443053 yellow 14-443023 green 14-441053 yellow
  • Manufacturer
    Zimmer Biomet

Manufacturer

Zimmer Biomet
  • Dirección del fabricante
    Zimmer Biomet Red Dragon Court, Unit 2, South Road Bridgend Industrial Estate Bridgend South Wales CF13 3PTTel: 01656 333932 Email: fieldaction.uk@zimmerbiomet.com
  • 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
    MHRA