Events

Alerta De Seguridad para surgical instrument for ready cable system and arthroplasty

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 Inc.

¿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
    I1606-233
  • Número del evento
    2009DM-0003223
  • Fecha
    2016-06-03
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=138
  • 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 there is a possibility of tears or holes in the container that contains the components of the implant, affecting the sterile barrier of the device, which could lead to the potential occurrence of adverse events on patients.

Device

surgical instrument for ready cable system and arthroplasty
  • Modelo / Serial
    Trabecular Metal Knee Implant, specific lots distributed between April 2011 and March 2016.
  • Descripción del producto
    Instruments used for READY cable system implants and hip, knee, shoulder and elbow prostheses. They are used for the preparation of the bone surface and the insertion of the extraction and the alignment of the decath prosthesis, shoulder and elbow.
  • Manufacturer
    Zimmer Inc

Manufacturer

Zimmer Inc
  • 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