Events

Alerta De Seguridad para Name of product: VANGUARD PS KNEE SYSTEM Technical Name: TOTAL KNEAD PROSTHESES ANVISA Registration Number: 80044680074 Hazard Class: III Model Affected: 183102, 183106, 183108, 183110, 183122, 183126, 183128, 183130 Serial numbers Affected: J3829966 ; J3814228; J3815898; J3815900; J3772614; J3798256; J3798264; J3802755; J3775002; J3802707; J3783505; J3854432; J3854477; J3854480; J3783510; J3847226; J3797465; J3830678; J3830680; J3847177; J3848966; J3812141; J3850667

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Biomet Orthopedics, 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
    2067
  • Fecha
    2017-01-23
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • Notas adicionales en la data
    Contact the manufacturer for product recall.
  • Causa
    Zimmer biomet is conducting a recall of some batches of the vanguard femoral component due to incorrect labeling of some components from 05/04/2016 to 09/01/2016. as a result, some components were labeled with smaller or larger size and / or the wrong side (right / left). at the moment of use, it is easy to detect the incorrect label, since the product has correct laser marking.
  • Acción
    Field Action Code 2016-262 triggered under the responsibility of Biomet 3I of Brazil. Company will make collection for later return to the manufacturer.

Device

Name of product: VANGUARD PS KNEE SYSTEM Technical Name: TOTAL KNEAD PROSTHESES ANVISA Registrati...

Manufacturer

Biomet Orthopedics, 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
    ANVSANVISA