Device Recall Oxford Fixed Bearing Partial Knee Replacement

  • 모델명 / 제조번호(시리얼번호)
    M300790, M632920, M539410, M444850, M987620, M987310
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154223 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size D5 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • 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 28 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    M619730 , M480920, M656920, M938460, M444630
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154200 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A3 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M619740, M492940, M444640, M656930, M938470
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154201 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A4 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M879630 , M584360, M492950, M444650, M656940, M938480
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154202 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A5 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M879640, M375460, M444660, M886350, M938490
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154203 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A6 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    M375470, M444680 , M886360, M938500
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
  • 제품 설명
    REF 154204 Oxford Fixed Bearing Partial Knee || Cemented Lateral Tibia || Size A7 ARCOM UHMWPE / CO-CR-MO Alloy || Only for use in Lateral compartment || Sterile R || The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
  • Manufacturer
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