Events

Device Recall Dental cement under the brand name CementIt and Natural Elegance 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Kerr/pentron Dba Kerr Corporation And Pentron Clinical 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
    60359
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0454-2012
  • 사례 시작날짜
    2011-03-17
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105131
  • 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
    Cement, dental - Product Code EMA
  • 원인
    The firm initiated a recall because the product sets faster than specified in the "directions for use" and in release specifications.
  • 조치
    The firm, Pentron Clinical, sent an " URGENT: MEDICAL DEVICE RECALL" letters dated April 4, 2011 and April 20, 2011 via USPS 1st class mail to its customers. The letter describes the product, problem and actions to be taken. The letter instructed customers to review the table with affected product lots and determine if the affected products was in their inventory; return the affected product for a replacement at no charge; contact Pentron Clinical Customer Service at (800) 551-0283; 1-800-243-3969 ext. 677 or email: aestridge@pentron.com directly to handle the arrangements of a quick return and replacement; and complete and fax back the enclosed Recall Return Form at 1-877-677-8844. The letter also request the customer to identify and recover the affected product lots that may have been shipped to thier customers. If you have any questions, contact Pentron Clinical Customer Service at (800) 551-0283.

Device

Device Recall Dental cement under the brand name CementIt and Natural Elegance
  • 모델명 / 제조번호(시리얼번호)
    Product under the brand name Cement-It: Part No. N33, N33A; Syringe Lot No. 183058; Package Lot No. 186272, 186665, 186676.  Product under the brand name Natural Elegance (Private Label of Cement-It): Part No. SHN9004110; Syringe Lot No. 183058; Package Lot 182990, 186133, 188996.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) including states of: PA, IL, NV, WA, OH, TN, WI, NY, NJ, CT, IN FL, MI, OK, NE, HI, VA, CA, and TX; and countries of : Canada, Egypt, Isreal, Netherlands, Sweden and UK.
  • 제품 설명
    Dental cement under the brand name Cement-It and Natural Elegance (private label of Cement-It). || The intended use of this device is to affix dental devices such as crowns or bridges onto the tooth. Cement-It and Natural Elegance (private label of Cement-It) are indicated as a luting cement bonding system for porcelain crowns, inlays, and onlays and other dental restorations, including ceramics, metal alloys and composite restoratives.
  • Manufacturer
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical

Manufacturer

Kerr/pentron Dba Kerr Corporation And Pentron Clinical
  • 제조사 주소
    Kerr/pentron Dba Kerr Corporation And Pentron Clinical, 1717 W. Collins Ave, Orange CA 92867
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA