Device Recall Vanguard PS Open Box Femoral 70MM Left Interlok

  • 모델명 / 제조번호(시리얼번호)
    Part # 183132.  Lot # 947480.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: (USA) Nationwide including the states of NJ, PA, LA, SD, TX, and KS; and the country of The Netherlands.
  • 제품 설명
    Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. || Biomet, Inc. || A knee joint replacement prosthesis non-coated femoral indicated for cemented application only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582-6989
  • 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