Retiro De Equipo (Recall) de Vanguard Complete Knee System

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Zimmer Biomet, Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    79161
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0673-2018
  • Estado del evento
    Open, Classified
  • País del evento
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Causa
    Knee implant components (tibial bearings) are labeled with the incorrect size.
  • Acción
    Zimmer Biomet sent an Urgent Medical Device Recall letter dated September 29, 2017 to their customers. The letter identified the affected product, problems and actions to be taken. Customers were instructed to remove the affected product from inventory and provide to their Zimmer sales representative or, if the consignee is a distributor, to ship the affected product back to Zimmer. Consignees were also asked to complete a recall response form and send this back to the firm. Returns are being physically destroyed. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Device

  • Modelo / Serial
    Lot Number: 388680, Exp. Date 5/19/2022
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
  • Descripción del producto
    Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442 || Product Usage: || For use in total knee arthroplasty
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • Empresa matriz del fabricante (2017)
  • 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
    USFDA