Norian CRS Rotary Mixer Cement 10cc sterile 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Synthes USA (HQ), Inc. 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
    53496
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0269-2010
  • 사례 시작날짜
    2009-09-14
  • 사례 출판 날짜
    2009-11-16
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-03-08
  • 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
    Methyl Methacrylate For Cranioplasty - Product Code GXP
  • 원인
    Non-conforming material - increased set time. potential clinical ramifications associated with increased set time and decreased strength include extrusion of unset material and fragmentation of cured material. the risk of norian fragmentation post cure increases with a larger defect and a thicker layer of product. customers were advised to call synthes at 1-800-479-6329 to obtain a return autho.
  • 조치
    The firm issued an Urgent Medical Device Recall letter dated 9/17/09 via USPS certified mail. The letter informed customers of the problem and the need to return the product. Sales Consultants that were shipped the device were notified by teleconference on 9/14/09. Consultants were instructed to go to their accounts to remove the product from inventory. Customers were advised to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Questions are directed to Synthes at 800-620-7025 x 5453 or 610-719-5453 or to your Synthes CMF Sales Consultant.

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number 614.10.01S. Lot number N996352
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    The product was shipped to medical facilities in CO, KS, MA, MO, NY, SC, TX, UT, and WA.
  • 제품 설명
    Norian CRS Rotary Mixer Cement 10cc sterile
  • Manufacturer

Manufacturer

  • 제조사 주소
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • 제조사 모회사 (2017)
  • Source
    USFDA