Events

Device Recall Maxcem Elite 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Henry Schein, 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
    60407
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0390-2012
  • 사례 시작날짜
    2011-11-10
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-07-03
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105261
  • 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 specific lots of maxcem elite refill kit appear not to be authentic.
  • 조치
    The firm, Henry Schein, Inc., sent an "URGENT: Product Recall (Dental Practitioners/User Level) letter and response form dated November 10, 2011, via first class mail to its customers. The letter instructed the customers to examine their inventory to verify if they have any of the specified lots on hand. If so, remove it from their shelves. The product may be returned for credit within 30 days, to the following address: Henry Schein, Inc., 41 Weaver Road, Denver, PA 17517. Additionally, the letter instructed the customers to complete, sign, date, and return the enclosed Henry Schein Response Form via fax to: (631) 843-5557 or mail to: Regulatory Affairs Department (E-355) 135 Duryea Road, Melville, NY 11747, Attn: Regulatory-RR. The letter stated "Only returns of the above noted recalled item/lot numbers purchased from Henry Schein, Inc. will be credited to your account. In order to expedite your credit, please include a copy of your response form and invoice, if available, with your return". If you have any questions regarding this matter, please contact Recall Coordinator at 631-390-8000 ext. 8476.

Device

Device Recall Maxcem Elite
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers 3285932 (exp. 01/2011), 3461229 (exp. 11/2011), 3566373 (exp. 05/2012) ; HSI number 123-7426
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA (nationwide) and countries of: Bermuda, Martinique FWI, Nassau Bahamas, St Maarten NA, Australia, and South Africa.
  • 제품 설명
    Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872, CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips || Dental resin cement. Self-etch, self-adhesive resin cement. High bond strength without adhesive needed. Easy to clean up and can be used with all anterior and posterior ceramics, PFMs, and CAD/CAM materials. Color stable and aesthetic. Works with all substrates from opaque to translucent.
  • Manufacturer
    Henry Schein, Inc.

Manufacturer

Henry Schein, Inc.
  • 제조사 주소
    Henry Schein, Inc., 135 Duryea Rd, Melville NY 11747
  • 제조사 모회사 (2017)
    Henry Schein Inc
  • Source
    USFDA