Events

Device Recall 37 Etching Gel1ml syringe 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
    60114
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0154-2012
  • 사례 시작날짜
    2011-03-31
  • 사례 출판 날짜
    2011-11-03
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-08-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104458
  • 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
    Pentron clinical is voluntarily recalling all lots of products labeled as 37% phosphoric acid etching gel produced since april 2007 because the product continues to extrude out of the syringe even after pressure is no longer applied, and it contains a higher percentage of phosphoric acid than that indicated on the label.
  • 조치
    The firm, Pentron Clinical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated May 31, 2011, with attached Return Form (via USPS 1st class mail) to all their consignees/customers. The letter describes the product, problem and action to be taken. All consignees/customers were instructed to complete the Recall Return Form via fax to: 1-877-677-8844 and to return any affected product in their inventory. Affected products will have expiration dates between April 2011 and April 2015. Consignees/customers with questions can contact Pentron Clinical Customer Service at (800) 551-0283 directly to handle the arrangements of a quick return and replacement.

Device

Device Recall 37 Etching Gel1ml syringe
  • 모델명 / 제조번호(시리얼번호)
    all lots of products labeled as 37% Phosphoric Acid Etching Gel produced since April 2007
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Armenia, Austria, Australia, Antigua & Barbuda, Barbados, Belarus, Bulgaria, Canada, Czech Republic, Croatia, Cyprus, Ecuador, El Salvador, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Kenya, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Poland, Romania, Russia, St. Vincent & Grenadine, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, UAE, Ukraine, UK, and Vietnam.
  • 제품 설명
    37% Etching Gel-1ml syringe 50 pk, part # T06B || The intended use of these devices is to etch tooth dentin/enamel in order to prepare the tooth surface prior to the application of a bonding agent.
  • 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