Events

TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew Surgical 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-2014-RN-00757-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-07-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00757-1
  • 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 manufacturer has identified a manufacturing error which results in the proximal lag screw being positioned incorrectly. in the event an incorrectly positioned proximal lag screw hole inhibits drilling and causes the user to hit the nail, the following issues could occur: the nail is removed and/or the procedure is delayed, the nail’s fatigue life is reduced, causing the nail to fail within a short period of time.
  • 조치
    The affected customer has been requested to inspect their inventory and quarantine the affected stock. The local Smith & Nephew Surgical representative will contact the customer to arrange for the product to be returned.

Device

TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D
  • 모델명 / 제조번호(시리얼번호)
    TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125DBatch Number: 14CM03676Model Number: 71675206ARTG Number: 104370
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd