Events

Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Alphabond Dental 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-00621-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-15
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00621-1
  • 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
    The product recall is implemented by the manufacturer, alphadent nv as a result of the cancellation of the company's ce certificate of conformity. alphadent nv has not received any injury reports relating either directly or indirectly to the medical devices (ceka attachments) subject to this recall. however, as a precautionary measure and in order to ensure compliance with applicable legislative requirements, alphadent nv has decided to initiate a recall of the concerned medical devices manufactured from 13 september 2013 with batch number 13091 and subsequent batches.
  • 조치
    Alphadent is advising users to inspect stock and quarantine any remaining stock for return or credit.

Device

Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Pre...
  • 모델명 / 제조번호(시리얼번호)
    Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-ClipBatch Number: 13091 and subsequent Manufactured from 13 September 2013ARTG Number: 108721
  • Manufacturer
    Alphabond Dental Pty Ltd

Manufacturer

Alphabond Dental Pty Ltd