Events

MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction) 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-2015-RN-01008-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-10-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01008-1
  • 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 is informing users of the known risk potentially associated with over-expansion of the small-sized mopyc stem (ptr-s7) that can result in its postoperative fatigue fracture.Although the operating technique emphasises the fact that stem expansion should only be performed when rotation instability is observed in the shaft, tornier noticed that the stems which were subject to fracture were over-expanded. tornier is providing users with a surgical technique addendum to emphasise this key point of the operating technique and to avoid unnecessary stem expansion that may be harmful for the patient.
  • 조치
    Tornier is providing users with a Surgical Technique Addendum to include further information regarding the risks of over expansion. This action has been closed-out on 25/08/2016.

Device

MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)
  • 모델명 / 제조번호(시리얼번호)
    MoPyc Radial Head Prosthesis Stem (used in elbow reconstruction)All batches manufactured since 2011ARTG Number: 94231
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd