Tissue expander 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mentor Texas, 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
    74895
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2747-2016
  • 사례 시작날짜
    2016-08-09
  • 사례 출판 날짜
    2016-09-07
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-03-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Expander, skin, inflatable - Product Code LCJ
  • 원인
    Tissue expander product mix found: cpx4 350cc was placed in a carton for the cpx4 450cc.
  • 조치
    The firm, Mentor, sent an "MEDICAL DEVICE REMOVAL" letter dated 8/11/2016 to affected consignees. The letter will be followed up with a respective sales representative visit. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately identify all unused units and return them per the normal return process; forward the letter to anyone your facility that needs to be informed; if you have sent these units to another facility, forward the letter to that facility; and maintain awareness of the letter until all units in your inventory have been returned. If you have any questions, please contact your local Mentor sales representative or Mentor Customer Service at 1-800-235-5731.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot 6981537
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
  • 제품 설명
    MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 || The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Mentor Texas, LP., 3025 Skyway Cir N, Irving TX 75038-3524
  • 제조사 모회사 (2017)
  • Source
    USFDA