Device Recall STAFlex SUBTALAR SCREW

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 625730 and 890910.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 13 mm x 19 mm, REF 982367, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • 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 6 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 890840 and 918570.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 7 mm x 13 mm, REF 982361, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 879260, 890850, and 894180.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 8 mm x 14 mm, REF 982362, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 879250, 890860, and 893930.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 9 mm x 15 mm, REF 982363, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 384950, 879290, and 890870.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 10 mm x 16 mm, REF 982364, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 144470 and 890880.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution.
  • 제품 설명
    STA-Flex SUBTALAR SCREW, 11 mm x 17 mm, REF 982365, Sterile, Biomet Sports Medicine, 56 East Bell Drive, Warsaw, IN. || Used to reduce excessive rearfoot pronation by blocking forward and downward displacement of the Talus, resulting in improved rearfoot alignment and foot function.
  • Manufacturer
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