Events

Cross-Link Clamp for Rods, 6.0 mm 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-00290-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-03-31
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00290-1
  • 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 pre-assembled cross-link clamp is used with 6mm longitudinal rods and 3.5mm transverse rods to provide additional rotational stability to long posterior thoracolumbar constructs. due to an error in production, the affected pre-assembled cross-link clamp cannot be securely attached to 6mm longitudinal rods. if the clamp does not tighten appropriately there is potential for surgical delay.
  • 조치
    Johnson & Johnson Medical is requesting end users to immediately identify and quarantine all unused products listed. Potentially affected product is to be returned to Johnson & Johnson Medical as soon as possible. This action has been closed-out on 4/08/2016.

Device

Cross-Link Clamp for Rods, 6.0 mm
  • 모델명 / 제조번호(시리얼번호)
    Cross-Link Clamp for Rods, 6.0 mmModel number: 498.813; 498.813SLot numbers: 2780518; 2781527; 2780516; 2780511; 2780509; 2780507ARTG number: 133401
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes