Events

Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Global Orthopaedic Technology 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-2015-RN-00002-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00002-1
  • 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
    Intrinsic therapeutics inc has identified a manufacturing defect affecting a select number of batches of the delivery tool (instrument). the defect can cause the instrument to break under stress during surgery. this defect does not impact the implant, its performance or possible safety of patients.
  • 조치
    1. Quarantined all stock on hand in the Global Orthopaedic Technology warehouse; 2. All Stock Recalled and physically had returned to Global Orthopaedic Technology warehouse that was on consignment with 1 hospital and on loan with second hospital. 3. All product recalled, quarantined and returned to the manufacturer. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy...
  • 모델명 / 제조번호(시리얼번호)
    Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)ARTG Number: 182175
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd