Device Recall Cylindrical Reamer

  • 모델명 / 제조번호(시리얼번호)
    96540
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 19.0 mm x 250 mm, REF 475826, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • 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 20 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    060890, 077020 and 605240.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 12.5 mm x 250 mm, REF 475813, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    180900 and 957590
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 13.0 mm x 250 mm, REF 475814, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    047610 and 833210
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 13.5 mm x 250 mm, REF 475815, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    18100
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 14.0 mm x 250 mm, REF 475816, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    605070
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA including states of: FL, OH, PA, IN, CA, and NJ; and countries of Argentina, Canada, Mexico, Netherlands and Spain.
  • 제품 설명
    Cylindrical Bullet Nose Reamer 7.0 mm x 250 mm, REF 475802, Biomet Orthopedics 66 East Bell Drive Warsaw IN. || The product is used to prepare the femoral canal for stem implantation.
  • Manufacturer
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