Device Recall Zimmer Hgp ii acetabular cup bone Screw

  • 모델명 / 제조번호(시리얼번호)
    LOTS: 63276979 63276976 63245682 63276975 63276977 63301523 63276980 63303436
  • 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
    Hgp ii acetabular cup bone screw selftap 6.5x15mm 00662406515 || Hgp ii acetabular cup bone screw selftap 6.5x20mm 00662406520 || Hgp ii acetabular cup bone screw selftap 6.5x25mm 00662406525 || Hgp ii acetabular cup bone screw selftap 6.5x35mm 00662406535 || Hgp ii acetabular cup bone screw selftap 6.5x55mm 00662406550 || Hgp ii acetabular cup bone screw selftap 6.5x60mm 00662406560
  • 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