Events

- Trade Name: Total Hip Prosthesis ** - Registration: 80062900002 ** - Risk Class: III - HIGH RISK ** - Validity: 21/2/2017 ** - Model: Muller Femoral Rod, Interchangeable Head C28 Cone Protek and Bipolar Head ** - Product Presentation: Sterile package containing 01 Total Hip Prosthesis composed of Bipolar Head, Interchangeable Head and Femoral Rod 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
    1334
  • 날짜
    2013-11-29
  • 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
    All distributors who have purchased the product are being informed by the company that the product should not be used and should be returned to the manufacturer for testing and analysis.
  • 원인
    During investigative inspection carried out by entities of the national sanitary surveillance system (snvs), there were detected failures in processes carried out by the company in the manufacture of the product. ## updated on 12/27/2013 - anvisa published resolution - re n ° 4,939, of december 23, 2013, determining the suspension of the dissemination, commercialization and implantation, throughout the national territory, of all products manufactured by the company ortobio for failing to comply with resolution 16/2013 of good manufacturing practices of medical products. (annex resolution - re no. 4,939, of december 23, 2013, published in official gazette no. 249, dated 12/24/2013, section i, page 74).
  • 조치
    - Stop the manufacture and marketing of the product. ** - Collection of products manufactured for the analysis and testing thereof. ** - The collection is being informed to customers by email and registered letter. The alert letter template is attached. ** - Monitor the behavior of the product in the market (products already implanted) by means of contact with the clients and doctors for whom the product was commercialized. It will be carried out according to the own form of the company, in Annex - Product Monitoring after sale. ## 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

- Trade Name: Total Hip Prosthesis ** - Registration: 80062900002 ** - Risk Class: III - HIGH RIS...

Manufacturer

ORTOBIO - IND E COM. DE PRODUTOS ORTOPEDICOS LTDA