Events

Dental implants and prosthetic components 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet Spain Orthopadic S.L (España), Para Biomet || Biomet 3i Dental Iberica, Sl || Lx Precision (Shanghai) Co., Ltd. De China Para Biomet 3i || De Estados Unidos De América. || Changzhou Biomet Medical Devices Co., Ltd (China) Para || Biomet 31 Estados Unidos 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
    R1608-370
  • 사례 연번
    2009DM-0004307
  • 날짜
    2016-08-31
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=124
  • 비고 / 경고
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 recall data from the U.S. and Colombia.
  • 데이터 추가 비고
  • 원인
    The manufacturer reports that it has detected that the referenced medical device was packaged in boxes that do not correspond to the product, despite the fact that the identification label is correct, leading to potentially confusions in the users and delays in the procedures.

Device

Dental implants and prosthetic components

Manufacturer

Unico Distribuidor: Biomet 3i Inc. || Biomet 3i Dental Iberica (Vlc) C/Islas Baleares || Biomet S...
  • 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
    NIDFSINVIMA