Device Recall Gentle Threads

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 905620 Lot: 824610
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
  • 제품 설명
    Gentle Threads Interference Screw 10x25mm Round Head. || An interference fixation screw for use in soft tissue reattachment procedures.
  • 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 7 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Part Number: 905627 Lot: 753410
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distribution-Domestic: None. International: Australia, Mexico, Chile, Costa Rica, Netherlands, and Brazil.
  • 제품 설명
    Gentle Threads Interference Screw 9x35mm Full Thread. || An interference fixation screw for use in soft tissue reattachment procedures
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot 326920
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
  • 제품 설명
    Gentle Threads, Interference Screw; Model No. 905607, for soft tissue reattachment procedures in the ankle/foot and knee.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot 326960
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
  • 제품 설명
    Gentle Threads, Interference Screw; Model No. 905608, for soft tissue reattachment procedures in the ankle/foot and knee.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot 207910
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
  • 제품 설명
    Gentle Threads, Interference Screw; Model No. 905617, for soft tissue reattachment procedures in the ankle/foot and knee.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    lot 326860, 326880
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Netherlands, Mexico, Paraguay, Brazil, Argentina, Malaysia, Costa Rica, Chile, South Korea, and Canada.
  • 제품 설명
    Gentle Threads, Interference Screw; Model No. 905604, for soft tissue reattachment procedures in the ankle/foot and knee.
  • Manufacturer
하나 더 2 건 더