Events

Notificaciones De Seguridad De Campo acerca de Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip

Según Health Sciences Authority (HSA), este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Singapore que fue producido por Asia Implant Support & Services.

¿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
    Field Safety Notice
  • ID del evento
    600:41/01-181/15/01_35
  • Fecha
    2015-10-02
  • País del evento
    Singapore
  • Fuente del evento
    HSA
  • URL de la fuente del evento
    https://www.hsa.gov.sg/announcements
  • Notas / Alertas
    Data from Singapore is current through September 2018. All of the data comes from the Health Sciences Authority (HSA), 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 Singapore.
  • Notas adicionales en la data
    Biomet 3i

Device

Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip
  • Modelo / Serial
  • Descripción del producto
    Narrow Right Angle Large Driver Tip and Narrow Right Angle Square Driver Tip, Biomet 3i
  • Manufacturer
    Asia Implant Support & Services

Manufacturer

Asia Implant Support & Services
  • 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
    HSAHSA