Device Recall Intramedullary Bone Saw

  • 모델명 / 제조번호(시리얼번호)
    Lot 239470, 457450
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • 제품 설명
    Part 475630, Intramedullary Bone Saw, Cam Assembly || Size 14 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot 239430, 239450
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • 제품 설명
    Part 475625, Intramedullary Bone Saw, Cam Assembly || Size 13 mm, || The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot 669420
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: NY, TX, MI, and M; to countries of: Australia and The Netherlands.
  • 제품 설명
    Part 475620 Intramedullary Bone Saw CAM Assembly || Size 12mm, || A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur.
  • Manufacturer