Events

Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Tornier 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-00973-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-01-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00973-1
  • 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
    Tornier sas has identified that some reversed cut guides have been incorrectly assembled during the manufacturing process. a faulty guide will generate an incorrect version measurement and may cause confusion or an improper humeral head resection. all the parts affected come from the same lot number (dp0213287).
  • 조치
    Tornier Pty Ltd have all the affected products within their warehouses or their distributors warehouses. Tornier is checking the stock or requesting the distributors to check the stock and if faulty guides are identified, will replace the faulty guides with new ones. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)
  • 모델명 / 제조번호(시리얼번호)
    Aequalis Ascent Flex Reversed Cut Guide (Instrument for use in the implantation of joint prostheses)Item Number: MWF011Lot Number: DP0213287ARTG Number: 112287
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd