Events

Alerta De Seguridad para Implant System and Dental 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 Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials.

¿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
    R1710-515
  • Número del evento
    2015DM-0003183-R1
  • Fecha
    2017-10-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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 has detected that the device may contain a manufacturing condition that affects the geometry of the driver's hexagonal characteristic, which prevents the components from being properly assembled, leading to possible delays in procedures and adverse events on the patients.

Device

Implant System and Dental Components
  • Modelo / Serial
    GEMLOCK 2.5mm RHD2.5, TSVKIT, specific lots
  • Descripción del producto
    Dental ZIMMER implant systems are designed for use in the maxilla or mandible for immediate loading or loading after the conventional healing period has elapsed. These implants can be used to replace the absence of one or more teeth. Immediate loading is indicated when there is good primary stability and adequate occlusal loading
  • Manufacturer
    Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials

Manufacturer

Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials
  • 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