Events

Device Recall SCORPIO PS 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-1682-2011
  • 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=93261
  • 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 LXH
  • 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 PS TIBIAL TRIAL
  • 모델명 / 제조번호(시리얼번호)
    T72-3-0108M SCORPIO PS TIBIAL TRIAL, SIZE 1, 8 MM T72-3-0110M SCORPIO PS TIBIAL TRIAL, SIZE 1, 10 MM T72-3-0112M SCORPIO PS TIBIAL TRIAL, SIZE 1, 12 MM T72-3-0115M SCORPIO PS TIBIAL TRIAL, SIZE 1, 15 MM T72-3-0118M SCORPIO PS TIBIAL TRIAL, SIZE 1, 18 MM T72-3-0121M SCORPIO PS TIBIAL TRIAL, SIZE 1, 21 MM T72-3-0124M SCORPIO PS TIBIAL TRIAL, SIZE 1, 24 MM T72-3-0308M SCORPIO PS TIBIAL TRIAL, SIZE 3, 8 MM T72-3-0310M SCORPIO PS TIBIAL TRIAL, SIZE 3, 10 MM T72-3-0312M SCORPIO PS TIBIAL TRIAL, SIZE 3, 12 MM T72-3-0315M SCORPIO PS TIBIAL TRIAL, SIZE 3, 15 MM T72-3-0318M SCORPIO PS TIBIAL TRIAL, SIZE 3, 18 MM T72-3-0321M SCORPIO PS TIBIAL TRIAL, SIZE 3, 21 MM T72-3-0324M SCORPIO PS TIBIAL TRIAL, SIZE 3, 24 MM T72-3-0508M SCORPIO PS TIBIAL TRIAL, SIZE 5, 8 MM T72-3-0510M SCORPIO PS TIBIAL TRIAL, SIZE 5, 10 MM T72-3-0512M SCORPIO PS TIBIAL TRIAL, SIZE 5, 12 MM T72-3-0515M SCORPIO PS TIBIAL TRIAL, SIZE 5, 15 MM T72-3-0518M SCORPIO PS TIBIAL TRIAL, SIZE 5, 18 MM T72-3-0521M SCORPIO PS TIBIAL TRIAL, SIZE 5, 21 MM T72-3-0524M SCORPIO PS TIBIAL TRIAL, SIZE 5, 24 MM T72-3-0708M SCORPIO PS TIBIAL TRIAL, SIZE 7, 8 MM T72-3-0710M SCORPIO PS TIBIAL TRIAL, SIZE 7, 10 MM T72-3-0712M SCORPIO PS TIBIAL TRIAL, SIZE 7, 12 MM T72-3-0715M SCORPIO PS TIBIAL TRIAL, SIZE 7, 15 MM T72-3-0718M SCORPIO PS TIBIAL TRIAL, SIZE 7, 18 MM T72-3-0721M SCORPIO PS TIBIAL TRIAL, SIZE 7, 21 MM T72-3-0724M SCORPIO PS TIBIAL TRIAL, SIZE 7, 24 MM T72-3-0908M SCORPIO PS TIBIAL TRIAL, SIZE 9, 8 MM T72-3-0910M SCORPIO PS TIBIAL TRIAL, SIZE 9, 10 MM T72-3-0912M SCORPIO PS TIBIAL TRIAL, SIZE 9, 12 MM T72-3-0915M SCORPIO PS TIBIAL TRIAL, SIZE 9, 15 MM T72-3-0918M SCORPIO PS TIBIAL TRIAL, SIZE 9, 18 MM T72-3-0921M SCORPIO PS TIBIAL TRIAL, SIZE 9, 21 MM T72-3-0924M SCORPIO PS TIBIAL TRIAL, SIZE 9, 24 MM All lots.
  • 의료기기 분류등급
    Orthopedic Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 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 PS 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