Events

Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Sybron Dental Specialties 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
    60693
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0989-2012
  • 사례 시작날짜
    2011-03-03
  • 사례 출판 날짜
    2012-02-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-10-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106241
  • 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
    Material, tooth shade, resin - Product Code EBF
  • 원인
    The recall was initiated because pentron clinical has confirmed that the flow tec nano-hybrid flowable composite material has been found to be difficult to extrude.
  • 조치
    Pentron Clinical sent an initial "URGENT: MEDICAL DEVICE RECALL" letter dated April 20, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to complete and fax back an enclosed recall return form in order to confirm their receipt of the recall notification. A second "URGENT: MEDICAL DEVICE RECALL" letter dated November 10, 2011 was sent to all affected customers because Pentron Clinical expanded the recall. On December 8, 2011 another recall communication was forwarded to all affected customers to change the wording on the letter to make it more clear to the customers about the recall expansion. Contact Pentron Clinical Customer Service at 1-800-551-0283 for questions regarding this recall.

Device

Device Recall Artiste Flowable and Flow Tec (private label of Artiste Flowable)
  • 모델명 / 제조번호(시리얼번호)
    All Lots
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA (nationwide) and the countries of Canada, Egypt, France, Germany, Italy, and Spain.
  • 제품 설명
    Flow Tec Nano-Hybrid Flowable Affected Product || Syringe Part No. Value Pack Part. No. Shade || BEN3784-514 BEN3786-754 A1 || BEN3784-532 BEN3786-763 A2 || BEN3784-541 BEN3784-738 A3 || BEN3784-550 BEN3784-747 A3.5 || BEN3784-569 BEN3784-756 A4 || BEN3784-578 BEN3784-765 B1 || BEN3784-596 BEN3784-774 B2 || BEN3784-603 BEN3784-783 C1 || BEN3784-612 BEN3784-792 C2 || BEN3784-621 BEN3784-809 C3 || BEN3784-649 BEN3784-818 D2 || BEN3784-722 BEN3784-818 Universal Opaque || BEN3784-685 BEN3784-827 A0 || BEN3784-701 BEN3784-836 Incisal. || The intended use of this device is as a light cured, low viscosity, hybrid composite material which is compatible with a variety of bonding agents and luting materials during the course of dental restorations. Artiste Flowable and Flow Tec (private label of Artiste Flowable) are indicated for restorations of carious lesions, porcelain repairs, small core build-ups, fill-in of surface enamel irregularities, etc.
  • Manufacturer
    Sybron Dental Specialties

Manufacturer

Sybron Dental Specialties
  • 제조사 주소
    Sybron Dental Specialties, 1717 W Collins Ave, Orange CA 92867-5422
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA