Device Recall NexGen Complete Knee Solution Stemmed Tibial Component

  • Modelo / Serial
    Lot Number: 61246477.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- US, Canada, Singapore Australia, and India.
  • Descripción del producto
    NexGen¿ Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. || Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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