Events

ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare 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-2012-RN-00853-3
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-08-23
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00853-3
  • 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
    There have been isolated reports of postoperative fever and inflammatory reactions (in the absence of bacterial infection) with use of actifuse abx in paediatric patients undergoing surgical removal of large juvenile bone cysts. the reported side effects had no negative impact on therapeutic outcome or function of the actifuse product. the instructions for use will be updated to include the reported problems as precautionary statement.
  • 조치
    Updated Instructions for Use (IFU) is being provided to all users of the affected devices.

Device

ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)
  • 모델명 / 제조번호(시리얼번호)
    ACTIFUSE ABX Synthetic Bone Substitute (artifical bone graft)All lot numbersARTG Number : 188736
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd