Device Recall NaturalKnee II Posterior Stabilized (P.S.) Condylar Tibial Inserts

  • 모델명 / 제조번호(시리얼번호)
    Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203
  • 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
    Natural-Knee¿ II Posterior Stabilized (P.S.) Condylar Tibial Inserts: || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS INS TIB SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ || N-K II CONS PS TIB INS SZ
  • 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