Events

Integra Suturable Duragen 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Integra LifeSciences Corporation 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
    14534
  • 사례 시작날짜
    2013-04-19
  • 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: Integra Neurosciences Pty Ltd (NZ), 5B Suite B, 331 Rosedale Road, Albany, Auckland 0632
  • 원인
    Specific lots of some collagen products may have deviated from a production process. the affected lots passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to a process deviation, they may have been released with higher levels of endotoxins that permitted by release specifications. higher endotoxin levels may result in fever in the immediate postoperative period. the manufacturer are not aware of any reports of patient injuries or other adverse events in connection with these product lots., the health hazard evaluation (hhe) provided by the manufacturer details that during an internal quality assurance review of processes, specific lots manufactured during the periods december 2010 to may 2011, and then december 2012 to february 2013, may possibly be affected.
  • 조치
    Product to be returned to supplier

Device

Integra Suturable Duragen

Manufacturer

Integra LifeSciences Corporation