Events

Device Recall Component of Ortho Development Balanced Knee Modular Tibial System. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ortho Development 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
    51926
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1229-2010
  • 사례 시작날짜
    2009-03-19
  • 사례 출판 날짜
    2010-04-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-06-30
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83873
  • 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
    Tibial Augment 5mm Block - Product Code JWH
  • 원인
    A component of knee prosthesis was assembled incorrectly.
  • 조치
    E-mail was sent to all agents and distributors on March 19, 2009 with illustrations and instructions on how to detect the upside down assembly and how to correct the problem if detected during surgery. Direct questions to the Ortho Development Corporation by calling 1-801-619-3444.

Device

Device Recall Component of Ortho Development Balanced Knee Modular Tibial System.
  • 모델명 / 제조번호(시리얼번호)
    Serial Numbers: 567-5101; 567-5102; 567-5103; 567-5104; 567-5105; 567-5106; 567-5201; 567-5202; 567-5203; 567-5204; 567-5205 and 567-5206.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    United States (AZ, FL, OR, TX and UT) and Japan.
  • 제품 설명
    5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. || The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from severe knee pain and disability. The indications for use are: 1) loss of joint configuration and joint function, 2) Osteoarthritis of the knee joint, 3) Rheumatoid arthritis of the knee joint, 4) Post-traumatic arthritis of the knee joint, 5) Moderate valgus, varus, or flexion deformities and 6) Revision procedures where other treatments or devices have failed.
  • Manufacturer
    Ortho Development Corporation

Manufacturer

Ortho Development Corporation
  • 제조사 주소
    Ortho Development Corporation, 12187 South Business Park Dr, Draper UT 84020
  • 제조사 모회사 (2017)
    Ortho Development Corporation
  • Source
    USFDA