Events

ACHILLON Minimally Invasive Achilles Tendon Suture System 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences 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-00825-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00825-1
  • 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
    Internal investigation by the manufacturer has identified that there is the possibility that one section of the outer package tyvek seal for the achillon suture system may not remain completely sealed if not used within its shelf-life of 5 years. the section of the seal affected is adjacent to the finger-lift used to open the outer blister and were it to occur the sterility assurance of the exterior surface of the inner package may be compromised. to date, no instances have been reported.
  • 조치
    Customers are requested to review their inventory and stop using the affected products immediately. Integra Neurosciences will advise customers on how to return the affected stock and provide credit or replacement products. This action has been closed-out on 10/05/2017.

Device

ACHILLON Minimally Invasive Achilles Tendon Suture System
  • 모델명 / 제조번호(시리얼번호)
    ACHILLON Minimally Invasive Achilles Tendon Suture SystemCatalogue Number: 119700NDAll Lot Numbers affectedARTG Number: 173933
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd