Events

List of Products in Annex .. SEE ALSO: 1334 ALERT; ALERT 1336; ALERT 1337. 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1345
  • 날짜
    2013-12-24
  • 사례 국가
    Brazil
  • 사례 출처
    ANVISA
  • 사례 출처 URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 Brazil.
  • 데이터 추가 비고
    According to the Field Action Notification Forms, in compliance with RDC 23/2012, the company is carrying out the product of metal bone screw (Registration No. 80062900003), and for the other products referred to in the Annex, it is carrying out an action of " Monitoring after sale of product ". However, Resolution RE 4.939 / 2012 is applicable to all company products, including those covered by Alerts 1334; 1336 and 1337.
  • 원인
    During investigative inspection carried out by entities of the national sanitary surveillance system (snvs), it was identified that the company does not comply with the quality requirements established by the good manufacturing practices of medical products established by rdc 16/2013. at the time, the manufacture of all products was suspended and the company's sanitary license was temporarily canceled. in addition, anvisa has ordered the suspension of the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by ortobio indústria e comércio de produtos ortopédicos ltda.
  • 조치
    The manufacture of ALL products was suspended; the products were banned at the time of inspection; the sanitary license was temporarily revoked. In addition to the measures adopted by the local VIA, ANVISA suspended the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by Ortobio Indústria e Comércio de Produtos Ortopédicos Ltda. ## UPDATED ON 05/20/201 - Publication of RESOLUTION - RE N ° 1,882, dated 05/16/2014, in DOU Nº 93 - Section 1, dated 05/19/2014, page 49, which partially revoked Resolution- RE nº 4.939, of December 23, 2013, releasing, throughout the national territory, the disclosure, commercialization and implantation of all the products listed in the table below, manufactured as of the publication date of this Resolution RE: . Orthoped Blocked Intramedullary Stem System - 80062900010; (ii). Blocking Screw for Intramedullary Rod - 80062900015; (iii). Titanium Threaded Anchor - 80062900011; (iv). Interference Bolt Romba Thread in Titanium -80062900017; (v). Sponge Bolt in Stainless Steel - 80062900018; (saw). Transverse Interference Screw - 80062900020; (vii). Special plates without rigid fixation for large and small fragments - 80062900014; (viii). Special plates blocked LPS in steel for large and small fragments - 80062900021. It should be noted that THE SUSPENSION OF THE DISCLOSURE, MARKETING AND IMPLANTS OF THE OTHER PRODUCTS MANUFACTURED BY THE COMPANY REMAINS IN FORCE. ##

Device

List of Products in Annex .. SEE ALSO: 1334 ALERT; ALERT 1336; ALERT 1337.

Manufacturer

ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA