Events

RECLAIM Distal Stem with Taper Sleeve Protector (Press-fit hip femur prosthesis) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd T/A Depuy Australia 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-2014-RN-00717-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00717-1
  • 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
    Johnson & johnson medical pty. ltd (jjm) is notifying surgeons of a change to the surgical procedure for all lots of reclaim taper sleeve protector because the product can be difficult to remove from the distal stem both before surgery and after proximal reaming.
  • 조치
    Johnson & Johnson Medical is advising surgeons to remove the Taper Sleeve Protector prior to implantation of the RECLAIM Distal Stem. JJM will remove the Taper Sleeve Protector from future Distal Stems.

Device

RECLAIM Distal Stem with Taper Sleeve Protector (Press-fit hip femur prosthesis)

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia