Events

TRIGEN SURESHOT Distal Targeting System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew Inc 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
    57047
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0411-2011
  • 사례 시작날짜
    2010-10-15
  • 사례 출판 날짜
    2010-11-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-02-17
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95238
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Orthopedic stereotaxic instrument - Product Code OLO
  • 원인
    Targeting software has been found to provide erroneous targeting when used with the 13 mm tan/fan left nails.
  • 조치
    Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.

Device

TRIGEN SURESHOT Distal Targeting System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers prior to and including ACA5
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.
  • 제품 설명
    smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc
  • 제조사 주소
    Smith & Nephew Inc, 1450 E. Brooks Rd, Memphis TN 38116
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA