Devices

Device Recall ROSA 3.0 (Brain application)

  • Modelo / Serial
    BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016,  BR16023, and BR16025.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
  • Descripción del producto
    ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. || Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
  • Manufacturer
    Zimmer Biomet, Inc.
  • 1 Event

Fabricante

Zimmer Biomet, Inc.
  • Dirección del fabricante
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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