Retiro De Equipo (Recall) de Device Recall Persona, The Personalized 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, 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    All lots of the persona cemented tibial drill, 5 degree cemented stemmed natural tibia implants, and associated tools including the tibial drill guide, broach, and sizing plate are being removed and replaced with enhanced products and instruments to reduce risks of tibial perforation which could result in tibial bone fracture due to the stress riser created by a perforation; tibial plate loosening.
  • Acción
    Zimmer sent distributors beginning the week of November 14, 2012, E-mail information requesting all equipment be collected in distributors office before shipment back to Zimmer and replacement. A telephone conference discussing the recall and amended surgical technique was held the week of November 14, 2012, and Urgent Recall notices were sent to Distributors describing the devices; risks; updated surgical technique with directions to hand deliver surgeon/risk manager letters to all affected surgeons and risk managers in hospitals receiving the product. The notices included directions to remove all affected product and ensure risk manager letter is provided. The letter stated a Zimmer Inc. employee will conduct onsite reconciliation and asked return of distribution Spreadsheet to within 24 hours of receiving notification. Product is to be returned with certificate of sterilization to Zimmer Product Service Department 1777 West Center St. Warsaw, IN 46580 or Zimmer International Logistics, Eschbach Germany for International Accounts. For questions regarding this recall call 574-372-4807.


  • Modelo / Serial
    Part Number 42-5399-064-01(left) Lot 62052717, 62079727, 62121519 Part 42-5399-064-02 (right) Lot 62055081, 62121526   Part Number 42-5399-064-02 (right)
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and internationally to Germany and Europe.
  • Descripción del producto
    Persona, The Personalized Knee System, Tibial Sizing Plate, Cemented, Nonsterile, Size C Left; Size C Right || This device is used with the Persona Knee System for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. o Collagen disorders, and/or avascular necrosis of the femoral condyle. o Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. o Moderate valgus, varus, or flexion deformities
  • Manufacturer


  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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