Devices

Device Recall ROSA 3.0 (Brain application)

  • 모델명 / 제조번호(시리얼번호)
    BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016,  BR16023, and BR16025.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA.
  • 제품 설명
    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

제조사

Zimmer Biomet, Inc.
  • 제조사 주소
    Zimmer Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 제조사 의견
    “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