Device Recall Coonmad/Morrey

  • 모델명 / 제조번호(시리얼번호)
    Catalog 32-8106-000-03; Lot 61644802
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution - USA nationwide and the countries of: Canada, Germany, Finland, Japan, Italy, San Juan, Switzerland, and UK.
  • 제품 설명
    COONMAD/MORREY TOTAL ELBOW || ELBOW COMPONENT REPLACEMENT SET || BUSHINGS & PINS FOR USE W/SIZE REGULAR ELBOW || ELBOW COMP REPLACEMENT-REG SET || STERILE PROD CLASS: 4100 || OPERATION:9000 || QTY/PKG:1 || Product Usage: || The ulnar and humeral components are connected by placing the hollow, outer axis pin across the two components and securing It with the solid Internal axis pin. The Inner and outer pin connection Is articulation point of the placement elbow.
  • 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