Events

Device Recall Knee replacement 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
    57705
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1740-2011
  • 사례 시작날짜
    2011-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97053
  • 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
    Components of a replacement knee system could be mislabeled.
  • 조치
    The firm, Ortho Development, sent a "Field Notification Memo" date January 7, 2011 to its customers. The memo described the product, problem and action to be taken. The customers were instructed to promptly return any remaining parts of the listed product; locate all the parts in their inventory; identify any of the listed parts that may have been used in surgery; verify the quantity they have on hand and the quantity used in surgery and reconcile them with the quantity sent; if discrepancy exists, notify customer service resolution; prepare items for return and contact customer service to obtain RMA number. Once reconciled, arrangements would be made for sending new inventory and the return of unused parts. If you have any questions regarding this issue, please notify Regulatory Affairs Manager at (801) 619-3450.

Device

Device Recall Knee replacement system
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 670675.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA including states of: AZ, CA, FL, MI, TX, and UT; and country of: Japan.
  • 제품 설명
    UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. || The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base for the metal femoral portion of the system, and moderates the degree of flexion afforded by the procedure.
  • 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