Events

Alerta De Seguridad para Zimmer handpiece systems

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Zimmer Surgical S.A..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    R1410-436
  • Número del evento
    2009DM-0004066
  • Fecha
    2014-10-28
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=192
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer informs that he has initiated the withdrawal of universal feeding systems from the referenced devices, detecting the possibility that the handpiece is activated by itself when it is connected to the power supply, leading to the generation of possible adverse events on the patient or the user.

Device

Zimmer handpiece systems
  • Modelo / Serial
    Universal Power Systems, specific serials.
  • Descripción del producto
    It is a modular system used for orthopedic surgery, consisting of modular handpieces, motors, to which its accessories and adapters can be connected, allowing great versatility and precision during orthopedic surgical procedures: drilling, sawing and milling. It can operate depending on the reference driven or activated by: air or nitrogen (pneumatic), or powered by electric power: continuous (battery) or alternating electrical power with power cable of the local power network. It is used in large and small bone surgeries of hip, knee, foot, hand, shoulder. And its intention of use is to be used in surgery rooms.
  • Manufacturer
    Zimmer Surgical S.A.

Manufacturer

Zimmer Surgical S.A.
  • 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
    NIDFSINVIMA