Events

3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2015-RN-00551-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00551-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Approximately 10% of users globally have reported to 3m that lava ultimate crowns de-bonded at a rate higher than their typical experience for crowns. the reported de-bond rates varied greatly and often significantly exceeded the 2-4% rates generally reported in clinical literature. based on customer feedback, the product is not meeting performance expectations for consistent and predictable outcomes for the crown indication.
  • 조치
    3M is notifying dentists of the issue and providing the Instructions for Use. Wholesalers are requested to return any remaining stock. This action has been closed-out on 20/06/2016.

Device

3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)
  • 모델명 / 제조번호(시리얼번호)
    3M ESPE Lava Ultimate CAD/CAM Restorative (Dental mill block)ARTG Number: 191737
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd