Devices

Device Recall Air Dermatome II

  • 모델명 / 제조번호(시리얼번호)
    Serial Number 500191 , 500192,500193, 500194,500196,500197,500198,500199, 500200, 500201,500202,500203, 500204, 500205,500206, 500207,500208,500209,500210, 500211,500212, 500213,500215,500216,500217, 500219,500220, 500221,500222, 500223, 500224, 500225,500226,500227,500228,500229,500230, 500231,500232, 500233,500234,500235,500236, 500237, 500238,500239,500240,500241 , 500242, 500243,500244,500245,500246,500247,500248,500249, 500250, 500251,500252,500253,500254, 500255,500256,500257,500258,500259, 500260,500261,500262,500263,500264, 500265,500266,500267,500268,500269, 500270,500291, 500292,500293,500295,500296,500297,500298, 500299,500300,500301 , 500302,500303, 500304, 500306, 500307,500308,500309,500310, 500331 , 500332, 500334, 500335, 500336, 500337, 500338, 500339, 500340, 500341,500342, 500343, 500344, 500345, 500346, 500347, 500348,500349, 500350, 500351 , 500352, 500353, 500354,500355, 500357, 500358, 500359, 500368, 500369,500370,500371
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
  • 제품 설명
    Zimmer Air Dermatome II, REF 00-8851-001-00 || handpiece || Rx, non-sterile || grafting instruments intended to provide variable graft thickness and width capabilities
  • Manufacturer
    Zimmer Surgical Inc
  • 1 Event

제조사

Zimmer Surgical Inc
  • 제조사 주소
    Zimmer Surgical Inc, 200 W Ohio Ave, Dover OH 44622-9642
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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

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Device Recall Air Dermatome II
  • 모델명 / 제조번호(시리얼번호)
    Serial Number 500311, 500312, 500317, 500320, 500321, 500322, 500323, 500324, 500325, 500326, 500327, 500328, 500329
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA Nationwide including Puerto Rico; UAE, TAIWAN, SWEDEN, THAILAND, KOREA, SINGAPORE, HONG KONG CHINA, CHILE, CANADA, AUSTRALIA, JAPAN, ENGLAND, GERMANY, and EGYPT.
  • 제품 설명
    Zimmer Air Dermatome II, REF 00-8851-001-01 || handpiece, w/o hose, Rx, non-sterile || grafting instruments intended to provide variable graft thickness and width capabilities.
  • Manufacturer
    Zimmer Surgical Inc