Events

NAJA Spinal Ligament Systems for Spinal Stabilization 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Evolution Surgical 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-2018-RN-00007-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-01-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00007-1
  • 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 manufacturer, cousin biotech, through post-market surveillance systems has identified three successive cases of breakage of the metal connector clamping system that occurred during surgery. for these three incidents, there were no serious clinical outcomes for patients except a slight increase in operating time to use another medical device.
  • 조치
    1. The letter should be passed on to end-users, to all persons concerned in your company, or to any other organization (healthcare centers) to which potentially affected products have been sent. 2. Check stock and quarantine all unused devices with the batch numbers identified. 3. Complete the supplied form and return it to the email address provided for the sponsor to arrange the collection of affected units.

Device

NAJA Spinal Ligament Systems for Spinal Stabilization
  • 모델명 / 제조번호(시리얼번호)
    NAJA Spinal Ligament Systems for Spinal StabilizationReference Numbers: RCBNAJ55LU, RCBNAJ55RUBatch Numbers - 141527, 141724, 141896, 151605, 151940, 151939, 152079, 152319, 171823, 170696, 172044, 151604, 152080ARTG Number: 273278 (Evolution Surgical Pty Ltd - Spinal internal fixation system, intervertebral body)
  • Manufacturer
    Evolution Surgical Pty Ltd

Manufacturer

Evolution Surgical Pty Ltd
  • Source
    DHTGA