Events

Sealapex Xpress(calcium hydroxide polymeric root canal sealant) 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-2017-RN-00314-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-03-07
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00314-1
  • 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
    A labelling error has been identified with a single lot of sealapex xpress. the product’s syringe label correctly identifies the expiration date as 2016-11. some carton labels incorrectly identify the expiration date as 2017-11. product used past the correct expiration date of 2016-11 may not perform as intended. such product may exhibit crystals in the catalyst paste.
  • 조치
    Kerr Endodontics is requesting distributors to identify customers with affected stock and to forward the customer letter to inform them of the issue. Customers with affected stock are requested to contact SybronEndo Customer Care in order to receive a RMA number to facilitate the return and replacement or credit of their affected products.

Device

Sealapex Xpress(calcium hydroxide polymeric root canal sealant)
  • 모델명 / 제조번호(시리얼번호)
    Sealapex Xpress(calcium hydroxide polymeric root canal sealant)Part Number: 33639Lot Number: 5-1310ARTG Number: 236668
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd