Events

Implant System and Dental Components 의 안전성 경고

National Institute of Drugs and Food Surveillance (INVIMA)에 따르면, 해당 안전성 경고 는 Colombia 에서 Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials 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
    R1710-515
  • 사례 연번
    2015DM-0003183-R1
  • 날짜
    2017-10-30
  • 사례 국가
    Colombia
  • 사례 출처
    INVIMA
  • 사례 출처 URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=65
  • 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 has detected that the device may contain a manufacturing condition that affects the geometry of the driver's hexagonal characteristic, which prevents the components from being properly assembled, leading to possible delays in procedures and adverse events on the patients.

Device

Implant System and Dental Components
  • 모델명 / 제조번호(시리얼번호)
    GEMLOCK 2.5mm RHD2.5, TSVKIT, specific lots
  • 제품 설명
    Dental ZIMMER implant systems are designed for use in the maxilla or mandible for immediate loading or loading after the conventional healing period has elapsed. These implants can be used to replace the absence of one or more teeth. Immediate loading is indicated when there is good primary stability and adequate occlusal loading
  • Manufacturer
    Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials

Manufacturer

Zimmer Dental Inc. || Zest Anchors, Llc Also Dba Zest Dental Solutions And Danville Materials
  • 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