Events

Device Recall Helioseal Clear 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ivoclar Vivadent, 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
    73308
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1026-2016
  • 사례 시작날짜
    2016-02-12
  • 사례 출판 날짜
    2016-02-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-05-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143819
  • 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
    Sealant, pit and fissure, and conditioner - Product Code EBC
  • 원인
    Complaints were received claiming the material failed to polymerize under the curing light. after investigation, it was determined that a wrong photo-initiator was used in the production batch u30755 of helioseal clear. this failure can lead to incomplete curing of the sealant, if mono-wave led curing lights are used.
  • 조치
    Ivoclar Vivadent sent an Urgent Medical Device Recall letter dated February 11, 2016, to all consignees via Certified Mail, Return Receipt Requested. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to complete, sign and return the attached acknowledgement form and return it to Ivoclar Vivadent via fax (716) 691-2294 or e-mail at recall.us@ivoclarvivadent.com. Contact Ivoclar Vivadent Customer Service at 1-800-533-6825 as soon as possible between the hours of 8:00 am and 6:00 pm EST Monday through Friday and a representative will arrange to pick up your affected materials for return and credit. Please notify your customers of this issue and return the product to us. For questions, please contact Ivoclar Vivadent Customer Service at 800-533-6825.

Device

Device Recall Helioseal Clear
  • 모델명 / 제조번호(시리얼번호)
    REF/Product Code/Art. No. 558521AN, Lot U29336 (exp. 10/5/2020); REF/Product Code/Art. No. 558520AN, Lots U33966, U35661, U50469 (exp. 10/5/2020)
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution including NY, PA, FL, IN, IA, TX, and CA.
  • 제품 설명
    Helioseal Clear Refill 1 x 1.25 g, REF/Product Code/Art. No. 558521AN and Helioseal Clear Assortment 5 x 1.25 g, REF/Product Code/Art. No. 558520AN ---- COMMON/USUAL NAME: Pit & Fissure Sealant
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.