Events

Device Recall Bond1 Primer/Adhesive 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
    54490
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1150-2010
  • 사례 시작날짜
    2009-08-24
  • 사례 출판 날짜
    2010-03-16
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-02-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=88580
  • 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
    Resin Tooth Bonding Agent - Product Code KLE
  • 원인
    Some of the material has been found to be gelled and therefore becomes unusable.
  • 조치
    An "Urgent Medical Device Recall" letter and "Recall Return Form" were sent by first class mail on August 24, 2009 to consignees. The letter acknowledged the "gelling" issue of identified lots shipped between July 2009 & August 2009. Customers were requested to return any of the remaining affected lots in their inventory. Contact Customer Service by calling 1-800-551-0283, (option 1) directly to handle the arrangements of a quick return and replacement.

Device

Device Recall Bond1 Primer/Adhesive
  • 모델명 / 제조번호(시리얼번호)
    Lots 186620, 190582 and 190985.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- United States, Canada, Netherlands, Sweden, Taiwan and Thailand.
  • 제품 설명
    Bond-1 Primer/Adhesive. || The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel.
  • 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