Events

Device Recall VKS Knee System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Plus Orthopedics USA 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
    34255
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0397-06
  • 사례 시작날짜
    2005-12-02
  • 사례 출판 날짜
    2006-01-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2007-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43345
  • 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
    Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
  • 원인
    The adjustment knob tower on one device was found to have broken off from the body of the instrument. this did not happend during a surgery and is believed to have been caused by the instrument being dropped or otherwise mishandled during hospital processing. a manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.
  • 조치
    The adjustment know tower on one device was found t have broken off from the body of the instrument. This did not happend during a surgery, and is belived tohave been caused by the instrument being dropped or otherwise mishandled during hospital processing. A manufacturer evaluation of the device determined that the laser weld attaching the knob to the body was not to specification.

Device

Device Recall VKS Knee System
  • 모델명 / 제조번호(시리얼번호)
    PI.79;  PI.79/I;  PI.79/IIII;  PI.80;  PI.80/III;  PI.80/IIII;  PI.80/IIIII
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Arizona, California, Colorado, Idaho, New York, Oklahoma, Texas, Utah, Wisconsin
  • 제품 설명
    VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
  • Manufacturer
    Plus Orthopedics USA

Manufacturer

Plus Orthopedics USA
  • 제조사 주소
    Plus Orthopedics USA, 10188 Telesis Ct, San Diego CA 92121-4779
  • Source
    USFDA