Events

Ethicon Physiomesh Composite mesh 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Johnson & Johnson International 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
    20208
  • 사례 시작날짜
    2016-05-30
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Johnson & Johnson Medical New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, AUCKLAND 1060
  • 원인
    Manufacturer has initiated worldwide medical device removal of product from the market., . health canada issued medical recall recall 25may2016 (ra-58846), . mhra recall 2016/005/025/701/005 -health care practitioners that have treated patients using ethicon physiomesh™ composite mesh should continue to follow those patients in the usual manner.This voluntary recall has been communicated to the u.S. ,food and drug administration (fda) and the european competent authorities.
  • 조치
    Product to be returned to supplier

Device

Ethicon Physiomesh Composite mesh
  • 모델명 / 제조번호(시리얼번호)
    Model: PHY0715R PHY1015V PHY1515Q PHY1520R PHY1520V PHY2025V PHY2030R PHY2535V PHY3035R and PHY3050R, Affected: All lots
  • Manufacturer
    Johnson & Johnson International

Manufacturer

Johnson & Johnson International