Events

Java Posterior stabilization System, 에 대한 현장 안전성 서한

Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems에 따르면, 해당 현장 안전성 서한 는 Czechia 에서 Zimmer Spine SAS 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Field Safety Notice
  • 사례 ID
    816
  • 날짜
    2016-11-01
  • 사례 국가
    Czechia
  • 사례 출처
    MHSIDCCCDMIS
  • 사례 출처 URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • 비고 / 경고
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and the Czech Republic.
  • 데이터 추가 비고

Device

Java Posterior stabilization System,
  • 모델명 / 제조번호(시리얼번호)
    Model Number: SN2023-1-00401 SN2023-1-00411 SN2023-1-00500 SN2023-1-00501 SN2023-1-00505 SN2023-1-00506 SN2023-1-00510 SN2023-1-00512 SN2023-1-00520 SN2023-1-00530 SN2023-1-00531 SN2023-1-00540 SN2023-1-00541 SN2023-1-00550 SN2023-1-00551 SN2023-1-00554 SN2023-1-00590 SN2023-1-00591 SN2023-1-00600 SN2023-1-00610 SN2023-1-00620 SN2023-1-00705 SN2023-1-00706 SN2023-1-00707 SN2023-1-00708 SN2023-1-00715 SN2023-1-00716 SN2023-1-00750 SN2023-1-00755 SN2023-1-00931 SN2023-2-00006 SN2023-2-00010 SN2036-1-00400 SN2036-1-00401 SN2036-2-00006 SN23-100400 SN23-100401 SN23-100410 SN23-100411 SN23-100500 SN23-100501 SN23-100510 SN23-100512 SN23-100515 SN23-100516 SN23-100520 SN23-100530 SN2023-1-00400 SN2023-1-00401 SN2023-1-00411 SN2023-1-00500 SN2023-1-00501 SN2023-1-00505 SN2023-1-00506 SN2023-1-00510 SN2023-1-00512 SN2023-1-00520 SN2023-1-00530 SN2023-1-00531 SN2023-1-00540 SN2023-1-00541 SN2023-1-00550 SN2023-1-00551 SN2023-1-00554 SN2023-1-00590 SN2023-1-00591 SN2023-1-00600 SN2023-1-00610 SN2023-1-00620 SN2023-1-00705 SN2023-1-00706 SN2023-1-00707 SN2023-1-00708 SN2023-1-00715 SN2023-1-00716 SN2023-1-00750 SN2023-1-00755 SN2023-1-00931 SN2023-2-00006 SN2023-2-00010 SN2036-1-00400 SN2036-1-00401 SN2036-2-00006 SN23-100400 SN23-100401 SN23-100410 SN23-100411 SN23-100500 SN23-100501 SN23-100510 SN23-100512 SN23-100515 SN23-100516 SN23-100520 SN23-100530 Batch Number: Všechny šarže
  • 제품 설명
    Inactive implantable medical devices
  • Manufacturer
    Zimmer Spine SAS

Manufacturer

Zimmer Spine SAS
  • 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
    MHSIDCCCDMIS