Device Recall Persona The Personalized Knee System, Natural Tibia

  • Modelo / Serial
    Part Number 42-5320-083-01 TIBIA SIZE H, LEFT, Lot: 11006513, 11006722, 11007119, 62018828, 62018829, 62033403, 62060748, 62068423, 62076595, 62079771, 62091371, 62110207, 62117667 Part Number 42-5320-083-02 TIBIA SIZE H, RIGHT, Lot: 11007062, 11007123, 62018830, 62018831, 62033404, 62051804, 62060749, 62068424, 62076597, 62079772, 62091372, 62117668, 77001707
  • 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, Natural Tibia, Cemented, 5 Degree Stemmed Tivanium Sterile || TIBIA SIZE H, LEFT || TIBIA SIZE H RIGHT || This device is indicated for patients with severe knee pain and disability due to: o 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
  • 1 Event


  • 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