Events

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Surgical 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-00406-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-05-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00406-1
  • 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
    Smith & nephew internal investigation found the packaging material and design to be insufficient to prevent the ultra fast-fix knot pusher suture cutter’s sharp edges from potentially puncturing the pouch and rendering the device unsterile. to date there have been no complaints or adverse effects associated with this issue.This could potentially lead to a post-operative infection.To date there have been no complaints or adverse effects associated with this issue.
  • 조치
    Smith & Nephew is advising their customers to inspect the inventory and quarantine the affected devices immediately. A Smith & Nephew customer service representative will contact the customer to arrange collection of any affected products and advise on substitute devices available. This action has been closed-out on 11/08/2016.

Device

ULTRA FAST-FIX Knot Pusher/Suture Cutter, Straight
  • 모델명 / 제조번호(시리얼번호)
    ULTRA FAST-FIX Knot Pusher/Suture Cutter, StraightProduct No: 72201537All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd