Events

Sinus-SuperFlex-635 Self-expanding Nitinol Stent System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pyramed 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-2015-RN-00701-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2015-08-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00701-1
  • 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
    An investigation of field complaints indicates an increased number of deployment issues. non-deployments were reported as well partial deployments of the stent. partially deployed stents may require additional intervention by a doctor due to stent elongation or fracture.This does not affect any patients with an implanted stent of this length since the problem may only occur during the implantation of the stent.
  • 조치
    Customers are advised to remove all affected products from their inventory and quarantine them in a separate area for collection by Pyramed Pty Ltd. This action has been closed-out on 18/02/2016.

Device

Sinus-SuperFlex-635 Self-expanding Nitinol Stent System
  • 모델명 / 제조번호(시리얼번호)
    Sinus-SuperFlex-635 Self-expanding Nitinol Stent SystemModel numbers: 8606-6200 and 8607-6200Lot Numbers: Q009591, Q009592, Q008259, Q010150 and Q015955ARTG Number: 178915
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd