Events

VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes 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-00733-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-08-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00733-1
  • 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
    This action is being initiated because the last hole on the veptr caudal rib supports, subject to this recall, may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
  • 조치
    Customers are asked to immediately check their inventory to determine if their facility has any affected product and to subsequently quarantine these units prior to returning them to JJM. This action has been closed-out on 29/08/2016.

Device

VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes