Events

3DKnee e Tibial Insert 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Encore Medical, Lp 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
    62801
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2302-2012
  • 사례 시작날짜
    2012-08-09
  • 사례 출판 날짜
    2012-08-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111744
  • 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 + additive/metal/polymer - Product Code OIY
  • 원인
    The firm is recalling one lot of 392-09-706, 3dknee e+ tibial insert, 9 mm, size 6, right. the shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
  • 조치
    DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.

Device

3DKnee e Tibial Insert
  • 모델명 / 제조번호(시리얼번호)
    Model Number 392-09-706, Lot Number 59602519
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution including Venezuela.
  • 제품 설명
    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. || The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • 제조사 주소
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA