Events

Novus TIGRR® Matrix Surgical Mesh 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Novus Scientific AB 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
    20455
  • 사례 시작날짜
    2016-08-01
  • 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: Clinical & Regulatory Services Limited, 50B Puketapu Road, Taradale, Napier 4112
  • 원인
    The product's instructions for use (ifu) have been updated based on the 3-year follow up of a clinical study. in the study the patients with direct (medial and combined) inguinal hernia showed relative high recurrence rates. the patient group is considered unable to form scar tissue strong enough to replace the mesh, leading to the conclusion that a permanent mesh is required.
  • 조치
    Instructions for use to be updated

Device

Novus TIGRR® Matrix Surgical Mesh
  • 모델명 / 제조번호(시리얼번호)
    Model: NSTM1015E, NST152OE and NSTM2030E, Affected:
  • Manufacturer
    Novus Scientific AB

Manufacturer

Novus Scientific AB