Events

Device Recall InterGuard 5.5mm Econo Refill 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
    72814
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0583-2016
  • 사례 시작날짜
    2015-12-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-10-19
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142285
  • 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
    Instruments, dental hand - Product Code DZN
  • 원인
    Ultradent is recalling interguard 5.5mm econo refill, lot#s bc2gn and bc4l7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
  • 조치
    Ultradent Products sent an Urgent Medical Device Correction letter dated December 21, 2015 to affected customers via FedEx. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discard remaining inventory. Replacement product will be sent to each of the identified customers upon completion. For questions regarding the recall call 801-553-4366 or 801-553-4220.

Device

Device Recall InterGuard 5.5mm Econo Refill
  • 모델명 / 제조번호(시리얼번호)
    lot#s BC2GN and BC4L7
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Austria, Canada, Colombia, Denmark, France, Germany, Great Britain, Iceland, and Portugal.
  • 제품 설명
    InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 || Product Usage: || InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
  • Manufacturer
    Ultradent Products, Inc.

Manufacturer

Ultradent Products, Inc.
  • 제조사 주소
    Ultradent Products, Inc., 505 W 10200 S, South Jordan UT 84095-3935
  • 제조사 모회사 (2017)
    Ultradent Products Inc
  • Source
    USFDA