Events

T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Synthes Australia 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-2014-RN-00852-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-07-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00852-1
  • 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’s assessment has identified that incorrect handling of the t-pal applicator instrument could potentially contribute to failure of the applicator inner shaft (pn 03.812.003) during insertion of implants or the non-detachable t-pal trial implants (pn 03.812.307-.317 and 03.812.507-517). as a result, the t-pal technique guide (pn 036.001.088) was updated to clarify instrument handling of the t-pal applicator (pn 03.812.001 applicator outer shaft, pn 03.812.004 applicator knob). if the inner shaft should break, the trial (or implant) spacer will no longer be secured in the 0° position. this rigid position is necessary for insertion. if the inner shaft should break in the pivoting position, the assembly cannot be properly advanced into the disc space.
  • 조치
    Synthes Australia is requesting their customers to replace the T-PAL Technique Guide with the updated version (PN 036.001.088, Version AD). This action has been closed-out on 03/06/2016.

Device

T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System)
  • 모델명 / 제조번호(시리얼번호)
    T-PAL (Transforaminal Posterior Atraumatic Lumbar Cage System) ARTG number: 153950
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd