Events

Affixus Hip Fracture Nail 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 Biomet Orthopaedics 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
    1364
  • 날짜
    2017-12-01
  • 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

Affixus Hip Fracture Nail
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 814309180 814309260 814309320 814309340 814309360 814309400 814309420 814309440 814309460 814311180 814311300 814311380 814311440 814311460 814313260 814313320 814409260 814409340 814409380 814409440 814411320 814411360 814411440 814509180 814509260 814509300 814509320 814509340 814509360 814509380 814509400 814509420 814509440 814511180 814511260 814511280 814511300 814511320 814511340 814511360 814511380 814511400 814511420 814511440 814513280 814513300 814513440 814513460 814609280 814609300 814609320 814609340 814609400 814609420 814609440 814611260 814611280 814611300 814611340 814611380 814611400 814611420 814611440 814611460 814613460 Batch Number: 398590, 507350, 595480, 788580, 893400, 398610, 512520, 666800, 788620, 893410, 406280, 535120, 669850, 788630, 893430, 437960, 535130, 701480, 788650, 893450, 438020, 535150, 701640, 858640, 893460, 438040, 535230, 701700, 858740, 893470, 459160, 535240, 701720, 858780, 893480, 459170, 535690, 701780, 858790, 893490, 459190, 555180, 701810, 858830, 893500, 459200, 555460, 701830, 858840, 935900, 459230, 555620, 701900, 858900, 935970, 459240, 555730, 701940, 858930, 936020, 459250, 555810, 702050, 858960, 936100, 459270, 581620, 702190, 858970, 936140, 459290, 581630, 702230, 862150, 942010, 480050, 581640, 737630, 862170, 942020, 480070, 581700, 737670, 892880, 942050, 480090, 581910, 760030, 892940, 942070, 480330, 581960, 760270, 892950, 972840, 507130, 581970, 788380, 892960, 972900, 507300, 582240, 788410, 892990, 973000, 507320, 582360, 788440, 893070, 507340, 582380, 788460, 893090,
  • 제품 설명
    Inactive implantable medical devices
  • Manufacturer
    Biomet Orthopaedics

Manufacturer

Biomet Orthopaedics
  • 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