Events

NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Integra Neurosciences 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-00353-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-04-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00353-1
  • 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 production process may have deviated during the manufacture of specific lots. the product lots in question passed all product finished goods testing, are sterile, and were tested and accepted for endotoxin levels. however, due to the process deviation they may have been released with higher levels of endotoxins than permitted by the specifications for the products.
  • 조치
    Integra is recalling the affected product and is asking clinicans to monitor their patients in the postoperative period in accordance with standard hospital or clinician protocol.

Device

NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Ne...
  • 모델명 / 제조번호(시리얼번호)
    NeuraGen Nerve Guide (Indicated for the repair of peripheral nerve discontinuities); NeuraWrap Nerve Protector (Indicated to provide nerve protection following peripheral nerve surgery)Catalogue Numbers: PNG130, PNG320, PNG520, PNG620, PNG630, NW320, NW340, NW520, NW540, NW740, NW1040Lot Numbers: 1112378, 1112106, 1112004, 1112030, 1111903, 1111938, 1105268, 1112038, 1111971, 1112104, 1112105, 1112297, 1111853, 1112107ARTG Numbers : 158870 and 158924
  • 의료기기 분류등급
    Neurological Devices
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd