Events

Device Recall 3M Unitek" Primary Stainless Steel Crowns 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company - Health Care Business 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
    66509
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0428-2014
  • 사례 시작날짜
    2013-06-05
  • 사례 출판 날짜
    2013-11-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122719
  • 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
    Crown, preformed - Product Code ELZ
  • 원인
    3m is recalling specific lots of 3m espe unitek primary stainless steel crowns - series ur4 contain ll3 crowns which are incorrectly labeled as ur4 crowns.
  • 조치
    3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-800-634-2249. For questions regarding this recall call 651-733-5718.

Device

Device Recall 3M Unitek" Primary Stainless Steel Crowns
  • 모델명 / 제조번호(시리얼번호)
    Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.
  • 제품 설명
    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns || Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • 제조사 주소
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA