Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee

  • Modelo / Serial
    Part Number: CP116574 Lot Number: 073840
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    This was a custom implant, there was only one (1) unit manufactured and distributed. The product has been implanted, so it is not subject to being returned.
  • Descripción del producto
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. || This Rotating Hinged Knee is intended to replace patient anatomy.
  • Manufacturer
  • 1 Event

Fabricante

  • 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