Events

Ultradent Products, Inc. Paper Points 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ultradent Products, 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
    77891
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3215-2017
  • 사례 시작날짜
    2017-08-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-01-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158141
  • 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
    Point, paper, endodontic - Product Code EKN
  • 원인
    The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
  • 조치
    The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.

Device

Ultradent Products, Inc. Paper Points
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers BD96Z, BDTDM, and BDTQ6
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
  • 제품 설명
    Ultradent Products, Inc. Paper Points, Size 25 PN #1554, 200 per container, sterile. || Product Usage: || The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • 제조사 주소
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3800
  • 제조사 모회사 (2017)
    Ultradent Products Inc
  • Source
    USFDA