Events

Instinct Java instruments and containers 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
    443
  • 날짜
    2016-03-04
  • 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

Instinct Java instruments and containers
  • 모델명 / 제조번호(시리얼번호)
    Serial Number: 046W1AN00100 046W1AN00105 046W1AN00200 046W1AN00201 046W1AN00210 046W1AN00211 046W1AN00240 046W1AN00250 046W1AN00300 046W1AN00301 046W1AN00302 046W1AN00310 046W1AN00320 046W1AN00321 046W1AN00322 046W1AN00340 046W1AN00345 046W1AN00370 046W1AN00411 046W1AN00500 046W1AN00505 046W1AN00506 046W1AN00520 046W1AN00530 046W1AN00540 046W1AN00541 046W1AN00542 046W1AN00550 046W1AN00551 046W1AN00554 046W1AN00555 046W1AN00560 046W1AN00565 046W1AN00570 046W1AN00580 046W1AN00585 046W1AN00590 046W1AN00610 046W1AN00620 046W1AN00640 046W1AN00641 046W1AN00650 046W1AN00660 046W1AN00661 046W1AN00670 046W1AN00700 046W1AN00701 046W1AN00745 046W1AN00755 046W1AN00765 046W1AN00775 046W1AN00800 046W1AN00810 046W1AN00820 046W1AN00823 046W1AN00824 046W1AN00830 046W1AN00831 046W1AN00832 046W1AN00845 046W1AN00855 046W1AN00865 046W1AN00875 046W1AN00885 046W1AN00930 046W1AN00931 046W1AN00950 046W2AN00032 046W2AN00033 046W2AN00034 046W2AN00035 046W2AN00060 046W2AN00061
  • 제품 설명
    Medical Supplies - Tools for Reuse
  • 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