Events

Maxcem Elite (Dental cement) 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-00198-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-03-04
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00198-1
  • 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
    It has come to the attention of kerr australia that an issue with the raw material used to produce the affected lots of maxcem elite causes the material to prematurely polymerise in the syringe. the product could be difficult to extrude or demonstrate a shorter work-time as the material may prematurely set prior to replacing restorations on the tooth or core build up. as a result, the restoration may not be sealed properly.
  • 조치
    Kerr Australia is requesting customers to review their stock and to determine if they have any affected lots. Any affected lots have been requested to be returned to Kerr Australia immediately.

Device

Maxcem Elite (Dental cement)
  • 모델명 / 제조번호(시리얼번호)
    Maxcem Elite (Dental cement)Multiple part numbers and lot numbersProduct with expiration dates through August 2015ARTG Number: 175450
  • Manufacturer
    Kerr Australia Pty Ltd

Manufacturer

Kerr Australia Pty Ltd