Device Recall Nex Gen Complete Knee Solution

  • 모델명 / 제조번호(시리얼번호)
    REF 00597001101, all codes
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) and the country of Japan.
  • 제품 설명
    00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; || 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; || 00597001201 Femur CR PRECOAT FEM COMP SIZE BML, Rx, Sterile; || 00597001202 Femur CR PRECOAT FEM COMP SIZE BMR, Rx, Sterile. || Used in total knee arthroplasty and indicated for patients with severe pain.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer, Inc., 345 E Main St, Warsaw IN 46580-2746
  • 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