Events

Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System 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-01090-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-11-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01090-1
  • 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
    Upon evaluation, depuy synthes discovered that certain lots of the screw inserter may potentially be etched with an incorrect graphic. the orientation of the etched image of the oblique angle on the screw inserter may be reversed which does not correspond to the tip of the angle of the instrument. this could result in the oblique cut at the lateral end of the screw being at a 90 degree angle to the lateral cortex.It is possible that the user would identify the final lateral oblique angle is not in the desired position, which could result in repositioning the screw within the nail so that the oblique angle of the screw is flush with the bone. the screw is designed to go in either orientation to allow proper depth placement of screw which is a critical factor for the success of the implant.
  • 조치
    JJM is requesting users inspect all devices in their possession and to quarantine all non-conforming stock prior to their return to JJM. This action has been closed-out on 29/08/2016.

Device

Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System
  • 모델명 / 제조번호(시리얼번호)
    Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing SystemPart number: 03.037.025Lot Numbers: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes