Events

3M ESPE Stainless Steel Primary Molar Crowns 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company / Medical Division 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
    57115
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0463-2011
  • 사례 시작날짜
    2010-10-06
  • 사례 출판 날짜
    2010-11-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95416
  • 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
    Unitek stainless steel permanent crowns with product codes 902150, 900213, and 900223, is mislabeled. the crown contained within the package is incorrectly labeled; series ul3 crowns are labeled series ur3 and vice versa. the lid of the package correctly identified the product number and lot. this mislabeling could result in placement on the right side of a crown intended for use on the left, and.
  • 조치
    3M ESPE issued a Device Recall letter dated October 6, 2010 to distributors and dentists. The letter listed the product being recalled including code and lot codes, background information including a picture of the product problem, and the recall procedure. The letter included a template letter to be used by distributors to inform their customers who have received the product. Mislabeled product is to be quarantined and returned to 3M ESPE. 3M ESPE can be contacted at 651 733-1110.

Device

3M ESPE Stainless Steel Primary Molar Crowns
  • 모델명 / 제조번호(시리얼번호)
    Product Code 900223 (Refill) " Lot codes N161092, N195115, N171401,N172028,N181008  Product Code 900213 (Refill) " Lot codes N161243, N168400, N181006, N186982, N195318  Product Code 902150 (Kit) " Lot Codes N155749, N170175, N193318
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution: Throughout USA, including the states of AZ, CA, GA, IL, IN, IA, LA, MA, MN, MO, NV,NJ, NY, NC, PA, TN, TX, WA, and WI. Canada and Dominican Republic
  • 제품 설명
    3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. || Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 || Product Code 900223, 900213, 902150
  • Manufacturer
    3M Company / Medical Division

Manufacturer

3M Company / Medical Division
  • 제조사 주소
    3M Company / Medical Division, 3M Center, Bldg 275-05-W-06, Saint Paul MN 55144
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA