Devices

Device Recall Nex Gen Complete Knee Solution

  • Modelo / Serial
    REF 00597001101, all codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the country of Japan.
  • Descripción del producto
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; || 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; || 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; || 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. || Used in total knee arthroplasty and indicated for patients with severe pain.
  • Manufacturer
    Zimmer, Inc.
  • 1 Event

Fabricante

Zimmer, Inc.
  • Dirección del fabricante
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • Empresa matriz del fabricante (2017)
    Zimmer Biomet Holdings
  • 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