Events

Straight Adjustable Gastric Band Product Code: 2200X & BD2XV 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical 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-2013-RN-01030-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-10-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01030-1
  • 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 manufacturer ethicon endo-surgery, has determined that the straight adjustable gastric band was unable to pass the internal test for 'force to close'. as a result surgeons may experience difficulty in locking the straight gastric band buckle during implantation. once the product is locked, the gastric band will remain in place and will function as intended.
  • 조치
    JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future.

Device

Straight Adjustable Gastric Band Product Code: 2200X & BD2XV
  • 모델명 / 제조번호(시리얼번호)
    Straight Adjustable Gastric Band Product Code: 2200X & BD2XVAll lot numbers affectedARTG Number: 94766
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd