Events

Notificaciones De Seguridad De Campo acerca de Personal Partial Knee Impactor Pad

Según Inspectie Gezondheidszorg en Jeugd, este evento ( notificaciones de seguridad de campo ) involucró a un dispositivo médico en Netherlands que fue producido por Zimmer Biomet.

¿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
  • Fecha
    2017-11-17
  • País del evento
    Netherlands
  • Fuente del evento
    IGJ
  • URL de la fuente del evento
    https://www.igj.nl/onderwerpen/waarschuwingen-medische-hulpmiddelen/documenten/waarschuwingen/2017/11/17/personal-partial-knee-impactor-pad-item-nr.-42539909100
  • Notas / Alertas
    The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, 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 the Netherlands.
  • Notas adicionales en la data
  • Causa
    Zimmer biomet is conducting a medical device correction to update the surgical technique for the persona partial knee impactor pad due to the potential for the pad to fracture. the issue is easily identifiable by users, and the impactor pad is made from radel blue, which is readily visible against human tissue to aid in the extraction of any fragments. as a result of this issue, the surgical technique has been updated to provide additional assembly instructions and to emphasize that the impactor pad is a single-use product provided non-sterile.

Device

Personal Partial Knee Impactor Pad

Manufacturer

Zimmer Biomet
  • 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. Note published by the authorities from the Netherlands: This message is a warning from the manufacturer. After placing a medical device on the market, the manufacturer is obliged to follow the device and, where necessary, to improve it. When there is a risk for the user, the manufacturer must take action. The manufacturer informs users and the inspection of this action with a warning (Field Safety Notice). See also medical device warnings. This is part of the supervision of medical technology.
  • Source
    IGJ