Device Recall NEXGEN COMPLETE KNEE SOLUTION, FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR

  • 모델명 / 제조번호(시리얼번호)
    REF 00-5901-026-00, Lots 61516146, 61522231, 61542077, 61550613, 61565681, 61584069, 61584438, 61594876, 61610343, 61637191, 61657309, 61659596, 61675231, 61691488, 61701224 and 61708918
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, Germany, Japan, New Delphi and Singapore. Addendum: Finland, Switzerland, UK, Denmark, Spain, Portugal, France, Netherlands, Italy, South Africa, Norway, Spain, and Sweden.
  • 제품 설명
    Posterior Referencing Instrumentation for the NEXGEN¿ COMPLETE KNEE SOLUTION, FEMORAL AND PROVISIONAL IMPACTOR/EXTRACTOR, REF 00-5901-026-00, Zimmer UK, Ltd.,, Zimmer Warsaw,IN || This instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Inc., 1800 W Center St, Warsaw IN 46580-2304
  • 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