Events

Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Kerr 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-2016-RN-00770-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-06-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00770-1
  • 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
    Kerr australia is recalling certain lots of herculite ultra, herculite xrv, point 4, and premise, where an issue with the production process used to package the affected lots may lead to the presence of plastic particulates in the dental composite material. the particulate is visible to doctors and should be easy to remove prior to or even after curing. the particulate is unlikely to cause any adverse health consequences.
  • 조치
    Kerr Australia is advising users that there is no need to replace any restorations placed with this material. Any remaining stocks of the affected product should be returned to Kerr.

Device

Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)
  • 모델명 / 제조번호(시리얼번호)
    Herculite Ultra, Herculite XRV, Point 4, and Premise Dental Composite (used in dental restoration)Multiple Lot Numbers and Part Numbers affectedShipped between June 2015 and April 2016ARTG Number: 99818
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd