Device Recall Microplasty Elite Instruments Vanguard Femoral Cutting Blocks

  • 모델명 / 제조번호(시리얼번호)
    Lots 083940 and 132602.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 65 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485154. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Biomet, Inc., 56 E Bell Dr, Warsaw IN 46582
  • 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 9 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lots 083700 and 132202.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 55 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485150. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 083730 and 132302.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 57.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485151. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 083760 and 132402.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 60 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485152. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 083830, 132502 and 132503.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 62.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485153. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lots 084280 and 132702.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution --- including USA and countries of Australia, Canada, Japan and the United Kingdom.
  • 제품 설명
    Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block, 67.5 mm, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-485155. A manual surgical instrument for general use; a non-powered, hand-held, or hand-manipulated device; instrument guide.
  • Manufacturer
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