Device Recall Apollo" Revision/Constrained Knee System

  • 모델명 / 제조번호(시리얼번호)
    Item Number 682000016 682001011 682001016 682001022 682001030 682002011 682002013 682002016 682002022 682002030 682003016 682003022 682003025 682004013 682004016 682005011
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
  • 제품 설명
    Apollo" Revision/Constrained Knee System: || SZ0-16MM AK CCK TIB INSER || SZ1-11MM AK CCK TIB INSER || SZ1-16MM AK CCK TIB INSER || SZ1-22MM AK CCK TIB INSER || SZ1-30MM AK CCK TIB INSER || SZ2-11MM AK CCK TIB INSER || SZ2-13MM AK CCK TIB INSER || SZ2-16MM AK CCK TIB INSER || SZ2-22MM AK CCK TIB INSER || SZ2-30MM AK CCK TIB INSER || SZ3-16MM AK CCK TIB INSER || SZ3-22MM AK CCK TIB INSER || SZ3-25MM AK CCK TIB INSER || SZ4-13MM AK CCK TIB INSER || SZ4-16MM AK CCK TIB INSER || SZ5-11MM AK CCK TIB INSER
  • 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