Events

Device Recall Epic Extremity Plate System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Epic Extremity, LLC 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
    79824
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1874-2018
  • 사례 시작날짜
    2018-03-20
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163592
  • 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
    Plate, fixation, bone - Product Code HRS
  • 원인
    There is an error in the caddy artwork that misidentifies a specific plate and screw.
  • 조치
    Notification letters were sent on 3/20/18. The letters instructed customers to: We ask you to be aware of the incorrect numbers and ensure you are ordering the correct part numbers until replacement parts are available. You will be informed promptly of the availability of the replacement trays. You will be contacted to arrange return and to exchange the parts presently in your possession. Our records indicate that you have received one or more of the trays involved. Therefore, we would ask you to reply to this memo and confirm the quantities of each tray in your possession. Your response will serve as acknowledgement of this notification and that you will act in compliance. Please reply to dschwartzbauer@EPICextremity.com. The notification letter included photographs of products to indicate errors in labeling.

Device

Device Recall Epic Extremity Plate System
  • 모델명 / 제조번호(시리얼번호)
    Catalog Number: 2111-0005 Lot: 51464
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The products were distributed to the following US states: FL, PA, and VA.
  • 제품 설명
    Epic Extremity Plate System, Midfoot/Flatfoot Insert, Part 2111-0005 with Extended Butterfly Plate (2000-5002)
  • Manufacturer
    Epic Extremity, LLC

Manufacturer

Epic Extremity, LLC
  • 제조사 주소
    Epic Extremity, LLC, 120 Marguerite Dr Ste 301, Cranberry Twp PA 16066-5007
  • Source
    USFDA