Events

NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation) 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-2013-RN-00983-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-09-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00983-1
  • 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
    Nx3 try-in gels allow for the restorations to be seated temporarily for review of their final appearance prior to cementation. kerr australia have received reports that some nx3 try-in gel syringes in the affected lot incorrectly contain a polishing paste. as the material in the affected syringe does not match the shade of the cement as it is labeled there is a risk that use of the affected material to evaluate shade prior to cementation may result in an unanticipated final restoration colour requiring the need to remove and repeat the restoration.
  • 조치
    Kerr Australia is requesting customers to stop using the affected product and return to Kerr Australia for replacement or credit.

Device

NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a t...
  • 모델명 / 제조번호(시리얼번호)
    NX3 Try-In Gel Syringe Refills, Bleach (dental material used to preview the expected shade of a tooth restoration before final cementation)Part Number: 33660Syringe Lot Number: 4580333Autobag Lot Number: 4584609Expiry date: February 2014ARTG Number: 176398
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd