Device Recall NexGen Complete Knee Solution Stemmed Tibial Component

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 61246477.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- US, Canada, Singapore Australia, and India.
  • 제품 설명
    NexGen¿ Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. || Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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