Device Recall Vitality Spinal Fixation System

  • 모델명 / 제조번호(시리얼번호)
    Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
  • 제품 설명
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Biomet Spine Inc., 10225 Westmoor Dr, Westminster CO 80021-2702
  • 제조사 모회사 (2017)
  • 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