Events

Alerta De Seguridad para Dental implants and prosthetic components

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 Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet Spain Orthopadic S.L (España), Para Biomet || Biomet 3i Dental Iberica, Sl || Lx Precision (Shanghai) Co., Ltd. De China Para Biomet 3i De || Estados Unidos De América. || Changzhou Biomet Medical Devices Co., Ltd (China) Para || Biomet 31 Estados Unidos.

¿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
    R1609-399
  • Número del evento
    2009DM-0004307
  • Fecha
    2016-09-23
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=121
  • 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 reports that it has detected that the medical device was packaged but was not sealed, which would compromise its sterile barrier, leading to potentially serious adverse events occurring in patients.

Device

Dental implants and prosthetic components

Manufacturer

Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet S...
  • 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