Events

Alerta De Seguridad para Tibial Alignment Guide – iAssist Knee System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Zimmer.

¿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
  • Fecha
    2015-05-22
  • Fecha de publicación del evento
    2015-05-22
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150522.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: zimmer tibial alignment guide – iassist knee system medical device manufacturer, zimmer, has issued a medical device safety alert concerning tibial alignment guide – iassist knee system. the affected device is identified as follows:- part number : 20-8011-013-00 lot numbers: 120265, 120659, 120659-1, 120793, 110623, 120794, 130134, 130135 based upon complaint investigation, the manufacturer has determined that the potential exists for the spikes on the iassist tibial alignment guide to bend or break during insertion or extraction from the tibia during use. the bending or breakage of the spikes is due to a stress riser at the junction of the spike and the main body of the instrument in combination with the presence of repeated high cyclic bending stresses from the impaction method utilised. these stresses are significantly increased when the proper steps of the surgical technique are not followed. if a spike breaks and goes unobserved, there is the possibility of a spike being left in the surgical site, which may result in a biocompatibility reaction (17-4ph stainless steel not assessed for long term biocompatibility) or interference with magnetic resonance imaging (mri), because of the magnetic stainless steel. the manufacturer is currently making preparations for repair or replacement. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 may 2015.

Device

Tibial Alignment Guide – iAssist Knee System
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Zimmer Tibial Alignment Guide – iAssist Knee System
  • Manufacturer
    Zimmer

Manufacturer

Zimmer
  • 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
    DH