Events

Device Recall UOC Femoral driver 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 United Orthopedic Corporation 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
    76540
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1692-2017
  • 사례 시작날짜
    2017-02-10
  • 사례 출판 날짜
    2017-03-01
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-06-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153467
  • 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 manual surgical instrument - Product Code LXH
  • 원인
    The locking lever pin component of the femoral driver may become deformed and break, resulting in malfunction during surgery and causing the device to become inoperable.
  • 조치
    United Orthopedic Corporation sent an Urgent Field Safety Notice dated January 19, 2017, to all affected consignees via e-mail on February 10. 2017. The Urgent Field Safety Notice instructed consignees to recover any affected units and return them to the manufacturer. A redesigned device will be sent for replacements. Consignees with questions were instructed to call 949-328-3366.

Device

Device Recall UOC Femoral driver
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers T16A178A (17 units); T16A178B (1 unit), T16A178B1 (3 units); T16A178C (12 units)
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US including State of CA and Internationally to Pakistan, Spain, and Taiwan.
  • 제품 설명
    UOC Femoral Driver, Product number PE 93045101, orthopedic manual surgical instrument/accessory for use during surgery to implant femoral components and femoral trial, and to remove femoral trial.
  • Manufacturer
    United Orthopedic Corporation

Manufacturer

United Orthopedic Corporation
  • 제조사 주소
    United Orthopedic Corporation, No. 57 Park Avenue 2, Science Park, Hsinchu Taiwan
  • 제조사 모회사 (2017)
    United Orthopedic Corp.
  • Source
    USFDA