Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-2016-RN-00980-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-22
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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
    Smith & nephew pty ltd is advising several lots of trigen internal hex captured recon screw blue 6.4mm x 65mm were supplied with incorrect instructions for use (ifu). the fracture fixation ifu (reference 81078017) was packaged with the device instead of the correct intramedullary nail system ifu (reference 81090283). affected products do not need to be returned. the affected products meet all other product specifications and can be used.
  • 조치
    Smith & Nephew are providing users with the correct Instructions for Use (IFU). This action has been closed-out on 23/05/2017.

Device

  • 모델명 / 제조번호(시리얼번호)
    Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)Model Number: 71642365Batch Numbers: 12BM01456, 12FM15060, 12JM09146, 13AM18101, 13EM08756, 13GM11807, 13GM11808, 13GM18304, 13GM20483, 13GM20486, 13HM20836, 15CM19083, 15FM02129ARTG Number: 104369
  • Manufacturer

Manufacturer