Device Recall Zimmer Selftapping bone screw

  • 모델명 / 제조번호(시리얼번호)
    LOTS: 63284570 63284572 63284573 63187350 63225662 63272712 63296123 63301504 63204283 63209528 63259476 63257719
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.
  • 제품 설명
    Trilogy self-tapping bone screw || Bone screw 4.5x25 selftap 00625004525 || Bone screw 4.5x50 selftap 00625004550 || Bone screw 6.5x15 selftap 00625006515 || Bone screw 6.5x20 selftap 00625006520 || Bone screw 6.5x25 selftap 00625006525 || Bone screw 6.5x30 selftap 00625006530
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 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