Device Recall Disposable Dowel Harvest Tube

  • 모델명 / 제조번호(시리얼번호)
    648210 and 648220.,
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    8 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900738, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • 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 3 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    019900, 019950 and 821060.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    10 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900740, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    705650 and 804380.
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    9 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900739, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    705630
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US, Canada, Australia, Chile, Argentina, Netherlands, Costa Rica and Japan.
  • 제품 설명
    7 MM DISPOSABLE DOWEL HARVEST TUBE WITH PROTECTION SLEEVE, REF 900737, Sterile, BIOMET Sports Medicine, Warsaw, IN 46581. || Usage: Bone Coring Device used in ACL and PCL procedures.
  • Manufacturer