All IMPLANTABLE PRODUCTS manufactured by the company. Locking System for Twister Column System - Registration: 80297610001 /// Hook for Twister column system - Registration 80297610002 /// Luminni cemented ceramic backplate - Register: 80297610003 /// Rods for column system Twister - Register: 80297610004 /// Stainless steel alloy femoral head - Registration: 80297610006 /// ET device - Registration 80297610007 - Luminni cobalt molybdenum chromium alloy femoral socket - Register: 80297610008 /// hexalobular and hexagonal Twister locking screw - Registration: 80297610013 /// PCL Cannulated Ligature Screw - Registration: 80297610015 /// PLS Solid Ligature Screw - Registration: 80297610016 /// Ancoraggi Titanium Bone Anchors - Registration 80297610017 /// Luminni Polyethylene Cement-Based Receptacle - Registration 80297610018 // / Femoral head of zirconia - Registration: 80297610019 /// Transverse locking connector - CTT - Registration: 80297610020 /// Femoral head of alumina - Regist Ro: 80297610021 /// Twister Bolts - Registration: 80297610022 /// Femoral stem of luminni chromium alloy - Registration: 80297610023 /// Titanium bone anchor Ancoraggi Eco - Registration: 80297610024 /// Cervical cage - Registration: 80297610025 // / ETD8 - Registration: 80297610026 /// Pins for garden technique - Registration: 80297610062 /// Suture screw - Registration: 80297610078 /// Lumini Cementless Rod - Register: 80297610079 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 Lima Corporate Indústria e Comércio de Produtos Médicos Hosp. 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
    1771
  • 날짜
    2015-12-21
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 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
    Company shall collect all batches / series of related products that have not yet been implemented. /// The company was notified by ANVISA to present a plan to follow up the patients who had implanted products and a Message model to the doctors clarifying in relation to the measures to be adopted with the patients who had implanted products.
  • 원인
    It was verified during investigative inspection that the company produces its products in disagreement with good manufacturing practices.
  • 조치
    ANVISA determined the suspension of manufacture, distribution, commercialization and implantation of all the IMPLANTABLE PRODUCTS previously related, as well as determined the collection of said products available in the market.