Device Recall Zimmer Plates and Screws

  • 모델명 / 제조번호(시리얼번호)
    LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831
  • 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
    Zimmer Plates and Screws (ZPS) || 3.5 mm Cortical Screw SelfTapping, 10 mm Length 47483501001 || 3.5 mm Cortical Screw SelfTapping, 14 mm Length 47483501401 || 3.5 mm Cortical Screw SelfTapping, 16 mm Length 47483501601 || 3.5 mm Cortical Screw SelfTapping, 24 mm Length 47483502401 || 3.5 mm Cortical Screw SelfTapping, 30 mm Length 47483503001 || 3.5 mm Cortical Screw SelfTapping, 40 mm Length 47483504001 || 3.5 mm Cortical Screw SelfTapping, 75 mm Length 47483507501
  • 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

유사한 이름을 가진 의료기기 1건 유사한 이름을 가진 의료기기 2 건

데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    LOT: 63292596
  • 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
    Zimmer Plates and Screws (ZPS) || 2.7 mm Cortical Screw SelfTapping, 14 mm Length 47482701401
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
    LOTS: 63303573 63282072 63303577 63303574 63296633 63295456 63296634 63198636 63295464 63296636 63296638 63301486 63301487 63301489 63296639 63248519 63298802 63298803 63287869 63248522 63317364 63317363 63248525 63298795 63320881 63287871 63317168 63248527 63317167 63287874 63248531 63248532 63248535 63248537 63293690 63293693 63293694 63305250 63298784 63284871 63298783 63249226 63305251 63312141
  • 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
    Zimmer Plates and Screws (ZPS) || 4.0 mm Cancellous Screw Fully Threaded, 12 mm Length 47484001200 || 4.0 mm Cancellous Screw Fully Threaded, 14 mm Length 47484001400 || 4.0 mm Cancellous Screw Fully Threaded, 16 mm Length 47484001600 || 4.0 mm Cancellous Screw Fully Threaded, 18 mm Length 47484001800 || 4.0 mm Cancellous Screw Fully Threaded, 20 mm Length 47484002000 || 4.0 mm Cancellous Scrwe Fully Threaded, 22 mm Length 47484002200 || 4.0 mm Cancellous Screw Fully Threaded, 26 mm Length 47484002600 || 4.0 mm Cancellous Screw Fully Threaded, 30 mm Length 47484003001 || 4.0 mm Cancellous Screw Fully Threaded, 32 mm Length 47484003200 || 4.0 mm Cancellous Screw Fully Threaded, 36 mm Length 47484003600 || 4.0 mm Cancellous Screw Fully Threaded, 40 mm Length 47484004000 || 4.0 mm Cancellous Screw Fully Threaded, 45 mm Length 47484004500 || 4.0 mm Cancellous Screw Fully Threaded, 50 mm Length 47484005000 || 4.0 mm Cancellous Screw Fully Threaded, 55 mm Length 47484005500 || 4.0 mm Cancellous Screw Fully Threaded, 60 mm Length 47484006000 || 4.5 mm Cortical Screw SelfTapping, 16 mm Length 47484501601 || 4.5 mm Cortical Screw SelfTapping, 18 mm Length 47484501801 || 4.5 mm Cortical Screw Self-Tapping, 20 mm Length 47484502001 || 4.5 mm Cortical Screw Self-Tapping, 22 mm Length 47484502201 || 4.5 mm Cortical Screw SelfTapping, 24 mm Length 47484502401 || 4.5 mm Cortical Screw SelfTapping, 26 mm Length 47484502601 || 4.5 mm Cortical Screw SelfTapping, 28 mm Length 47484502801 || 4.5 mm Cortical Screw SelfTapping, 34 mm Length 47484503401 || 4.5 mm Cortical Screw SelfTapping, 38 mm Length 47484503801 || 4.5 mm Cortical Screw SelfTapping, 40 mm Length 47484504001 || 4.5 mm Cortical Screw SelfTapping, 42 mm Length 47484504201 || 4.5 mm Cortical Screw SelfTapping, 54 mm Length 47484505401 || 4.5 mm Cortical Screw Self-Tapping, 58 mm Length 47484505801 || 4.5 mm Cortical Screw SelfTapping, 64 mm Length 47484506401 || 4.5 mm Cortical Screw SelfTapping, 66 mm Length 47484506601 || 4.5 mm Cortical Screw SelfTapping, 68 mm Length 47484506801 || 4.5 mm Cortical Screw SelfTapping, 70 mm Length 47484507001 || 6.5 mm Cancellous Screw Fully Threaded, 45 mm Length 47486504500 || 6.5 mm Cancellous Screw Fully Threaded, 55 mm Length 47486505500 || 6.5 mm Cancellous Screw Fully Threaded, 60 mm Length 47486506000 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 60 mm Length 47486506002 || 6.5 mm Cancellous Screw Fully Threaded, 65 mm Length 47486506500 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 65 mm Length 47486506502 || 6.5 mm Cancellous Screw Fully Threaded, 70 mm Length 47486507000 || 6.5 mm Cancellous Screw, 16 mm Thread Length, 80 mm Length 47486508001 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 80 mm Length 47486508002 || 6.5 mm Cancellous Screw, 32 mm Thread Length, 85 mm Length 47486508502
  • Manufacturer