Devices

Device Recall Zimmer

  • 모델명 / 제조번호(시리얼번호)
    lot no.: 61893774 61968082 62153448 62296426 62296426N 61983672 62153447 61827280 61920741 61964034 62108027 62108029 62153449 61835479 61878730 61878732 61940068 61940069 62121105 62121106 62121107 62121108 61621138 61878733 61929350 61940070 61940071 62086349 62086350 62086351 62086353 62086355 62086356 62153450 61763506 61878734 61878735 61940072 62121116 62121117 62121118 62121119 61878736 61929351 61940076 62121110 62121111 62121112 62121113 62103433 61597004 61597004N 61906259 61895931 61895932 61895933 61895935 61912972 61912975 61912976 61912977
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    Product 60 consists of all product under product code: HSB and same usage: || Item no: || 225207055 RECON SCREW LG 5.5MM DIA || 225207555 RECON SCREW LG 5.5MM DIA || 225208055 RECON SCREW LG 5.5MM DIA || 225208555 RECON SCREW LG 5.5MM DIA || 225209055 RECON SCREW LG 5.5MM DIA || 225209555 RECON SCREW LG 5.5MM DIA || 225210055 RECON SCREW LG 5.5MM DIA || 225210555 RECON SCREW LG 5.5MM DIA || 225211555 RECON SCREW LG 5.5MM DIA || 225212055 RECON SCREW LG 5.5MM DIA || 225213055 RECON SCREW LG 5.5MM DIA || Usage: || An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.
  • Manufacturer
    Zimmer Manufacturing B.V.
  • 1 Event

제조사

Zimmer Manufacturing B.V.
  • 제조사 주소
    Zimmer Manufacturing B.V., Turpeaux Industrial Park Rd 1 km 123.4, Mercedita PR 00715
  • 제조사 모회사 (2017)
    Zimmer Biomet Holdings
  • 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

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Device Recall Zimmer Plates and Screws
  • 모델명 / 제조번호(시리얼번호)
    LOTS: 63252354 63283819 63308551 63252355 63312340 63252350 63283820 63243831
  • 의료기기 분류등급
    Orthopedic Devices
  • 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
    Zimmer Manufacturing B.V.
Device Recall Zimmer Plates and Screws
  • 모델명 / 제조번호(시리얼번호)
    LOT: 63292596
  • 의료기기 분류등급
    Orthopedic Devices
  • 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
    Zimmer Manufacturing B.V.
Device Recall Zimmer Universal Locking System
  • 모델명 / 제조번호(시리얼번호)
    LOT: 63297474
  • 의료기기 분류등급
    Orthopedic Devices
  • 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 universal locking system (ULS) 3.5 mm cortical screw selftapping 18 mm length 47493501801
  • Manufacturer
    Zimmer Manufacturing B.V.
Device Recall Zimmer Periarticular Plating System
  • 모델명 / 제조번호(시리얼번호)
    LOT: 63146423
  • 의료기기 분류등급
    Orthopedic Devices
  • 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
    Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length || 47234702116
  • Manufacturer
    Zimmer Manufacturing B.V.
Device Recall Zimmer Plates and Screws
  • 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
    Orthopedic Devices
  • 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
    Zimmer Manufacturing B.V.
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