Events

Kerr Revolution Formula 2 Flowable Light Cure Composite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Patterson Dental Supply, 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
    57242
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0716-2011
  • 사례 시작날짜
    2010-10-15
  • 사례 출판 날짜
    2010-12-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-09-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95649
  • 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
    Tooth Shade Resin Material - Product Code EBF
  • 원인
    Patterson dental is conducting a recall because they have been advised by the manufacturer of revolution formula 2 (kerr corporation) that some syringes and tips marked with the brand name are not manufactured and distributed by kerr and, thus, not authentic product.
  • 조치
    Consignees were sent a Patterson Dental "Urgent Device Recall" letter dated October 15, 2010. The letter was addressed to "Valued Customer". The letter described the product and the problem. It also advised the consignees to quarantine and return the product with the specific distribution dates. Consignees were to complete and return the enclosed Recall Return Form along with the affected product. Questions should be directed to Nancy Strand at 651-686-1966 or nancy.strand@pattersondental.com.

Device

Kerr Revolution Formula 2 Flowable Light Cure Composite
  • 모델명 / 제조번호(시리얼번호)
    Shade A1 - Patterson Item # 434-4719;Kerr Part # 29493 Shade A2 - Patterson Item # 434-4727; Kerr Part # 29494 Shade A3 - Patterson Item # 434-4735; Kerr Part # 29495 Shade B1 - Patterson Item # 434-4768; Kerr Part # 29498
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- Including DC except VT.
  • 제품 설명
    SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A1, 20 - Dispensing tips, 29493. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A2, 20 - Dispensing tips, 29494. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes A3, 20 - Dispensing tips, 29495. || SDS Kerr Revolution Formula 2 Flowable Light Cure Composite. Net Wt. 4 g, Contents 4 Syringes (1g) each. This Package Contains 4 - 12 g Syringes B1, 20 - Dispensing tips, 29499. || Revolution is a flowable light cure hybrid resin restorative.
  • Manufacturer
    Patterson Dental Supply, Inc.

Manufacturer

Patterson Dental Supply, Inc.
  • 제조사 주소
    Patterson Dental Supply, Inc., 1031 Mendota Heights Rd, Saint Paul MN 55120
  • 제조사 모회사 (2017)
    Patterson Dental Supply Inc.
  • Source
    USFDA