Events

Excite F. DSC 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ivoclar Vivadent, 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
    66359
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0376-2014
  • 사례 출판 날짜
    2013-11-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-05-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122152
  • 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
    Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief - Product Code MZW
  • 원인
    Ivoclar vivadent, inc. is recalling a lot of excite f dsc dental adhesive found to produce a blue green discoloration when used in combination with cements.
  • 조치
    The firm, Ivoclar Vivadent, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated September 19, 2013 via first class mail to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to check your stock and segregate any material marked batch R59595; contact the Ivoclar Vivadent Customer Service at 800-533-6825 as soon as possible between the hours of 9:00am and 7:00pm EST Monday through Friday and a representative will arrange to have your stock replaced; both unopened and opened packages can be returned; and complete and return the Medical Device Recall Return Response Acknowledgment and Receipt Form. Please communicate locally with Ivoclar Vivadent Customer Service at 800-533-6825 for any questions.

Device

Excite F. DSC
  • 모델명 / 제조번호(시리얼번호)
    Product Code 630378AN; Lot Number: R59595; Expiration date of 3 January 2015
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution: including states of PA, WA, WI, NY, LA, TX, NJ, CA, OR, IA, SC, IN, IL, and AZ.
  • 제품 설명
    ExciTE F DSC Soft touch Single Dose, Dual-curing Regular Ref. 50 || dental adhesive for restorations
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.