Events

Device Recall SCORPIO CR TIBIAL TRIAL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Stryker Howmedica Osteonics Corp. 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
    56332
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1681-2011
  • 사례 시작날짜
    2010-07-13
  • 사례 출판 날짜
    2011-03-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93258
  • 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
    Stryker orthopaedics became aware that there is the potential for the scorpio t72 tibial insert trials to be oversized by a maximum of .024" (0.6mm).
  • 조치
    Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201-831-6069. For any questions customers were to call 201-972-2100 or 201-831-5028.

Device

Device Recall SCORPIO CR TIBIAL TRIAL
  • 모델명 / 제조번호(시리얼번호)
    T72-2-0308 SCORPIO CR TIBIAL TRIAL, SIZE 3, 8 MM T72-2-0310 SCORPIO CR TIBIAL TRIAL, SIZE 3, 10 MM T72-2-0312 SCORPIO CR TIBIAL TRIAL, SIZE 3, 12 MM T72-2-0315 SCORPIO CR TIBIAL TRIAL, SIZE 3, 15 MM T72-2-0318 SCORPIO CR TIBIAL TRIAL, SIZE 3, 18 MM T72-2-0321 SCORPIO CR TIBIAL TRIAL, SIZE 3, 21 MM T72-2-0324 SCORPIO CR TIBIAL TRIAL, SIZE 3, 24 MM T72-2-0508 SCORPIO CR TIBIAL TRIAL, SIZE 5, 8 MM T72-2-0510 SCORPIO CR TIBIAL TRIAL, SIZE 5, 10 MM T72-2-0512 SCORPIO CR TIBIAL TRIAL, SIZE 5, 12 MM T72-2-0515 SCORPIO CR TIBIAL TRIAL, SIZE 5, 15 MM T72-2-0518 SCORPIO CR TIBIAL TRIAL, SIZE 5, 18 MM T72-2-0521 SCORPIO CR TIBIAL TRIAL, SIZE 5, 21 MM T72-2-0524 SCORPIO CR TIBIAL TRIAL, SIZE 5, 24 MM T72-2-0708 SCORPIO CR TIBIAL TRIAL, SIZE 7, 8 MM T72-2-0710 SCORPIO CR TIBIAL TRIAL, SIZE 7, 10 MM T72-2-0712 SCORPIO CR TIBIAL TRIAL, SIZE 7, 12 MM T72-2-0715 SCORPIO CR TIBIAL TRIAL, SIZE 7, 15 MM T72-2-0718 SCORPIO CR TIBIAL TRIAL, SIZE 7, 18 MM T72-2-0721 SCORPIO CR TIBIAL TRIAL, SIZE 7, 21 MM T72-2-0724 SCORPIO CR TIBIAL TRIAL, SIZE 7, 24 MM T72-2-0908 SCORPIO CR TIBIAL TRIAL, SIZE 9, 8 MM T72-2-0910 SCORPIO CR TIBIAL TRIAL, SIZE 9, 10 MM T72-2-0912 SCORPIO CR TIBIAL TRIAL, SIZE 9, 12 MM T72-2-0915 SCORPIO CR TIBIAL TRIAL, SIZE 9, 15 MM T72-2-0918 SCORPIO CR TIBIAL TRIAL, SIZE 9, 18 MM T72-2-0921 SCORPIO CR TIBIAL TRIAL, SIZE 9, 21 MM T72-2-0924 SCORPIO CR TIBIAL TRIAL, SIZE 9, 24 MM T72-2-1108 SCORPIO CR TIBIAL TRIAL, SIZE 11, 8 MM T72-2-1110 SCORPIO CR TIBIAL TRIAL, SIZE 11, 10 MM T72-2-1112 SCORPIO CR TIBIAL TRIAL, SIZE 11, 12 MM T72-2-1115 SCORPIO CR TIBIAL TRIAL, SIZE 11, 15 MM T72-2-1118 SCORPIO CR TIBIAL TRIAL, SIZE 11, 18 MM T72-2-1121 SCORPIO CR TIBIAL TRIAL, SIZE 11, 21 MM T72-2-1124 SCORPIO CR TIBIAL TRIAL, SIZE 11, 24 MM All lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, South Africa, United Kingdom. and Canada.
  • 제품 설명
    SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • 제조사 주소
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA