Events

Aequalis Ascend Flex Shoulder System PTC Humeral Stems 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-2017-RN-00860-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00860-1
  • 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
    Wright medical has identified a deviation of the manufacturing method for one lot of aequalis ascend flex shoulder system ptc humeral stems. this is a documentary discrepancy with regulatory impacts, but for which the patient risk was assessed as negligible.The subcontractor (who have manufactured the affected parts), used in fact the manufacturing method validated for tornier sas internal manufacturing, whereas the justification for the authorisation to use this method by the subcontractor, was insufficiently documented.
  • 조치
    Measures to be taken by the customer: Wright Medical are asking that if any product is with customers, that they: 1. Locate and return parts; 2. Circulate this information to whom it may concern in the hospital; and 3. Inform a Tornier Representative of any adverse event.

Device

Aequalis Ascend Flex Shoulder System PTC Humeral Stems
  • 모델명 / 제조번호(시리얼번호)
    Aequalis Ascend Flex Shoulder System PTC Humeral StemsReference Number: DWF602CLot Number: AA2028ARTG Number: 234030
  • Manufacturer
    Tornier Pty Ltd

Manufacturer

Tornier Pty Ltd