Events

Device Recall OptraPol Polishing Discs 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
    74622
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2373-2016
  • 사례 시작날짜
    2016-07-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148060
  • 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
    Disk, abrasive - Product Code EHJ
  • 원인
    After a few seconds of polishing with moderate force, parts of the optrapol cup are breaking away. optrapol small flame is also affected. two complaints were filed referring to optrapol, claiming that the abrasive polishers wear faster than expected.
  • 조치
    URGENT MEDICAL DEVICE RECALL Letter (dated 7/11/2016) and Response Form were sent to customers on 7/11/2016 via Certified Mail, Return Receipt, Requested. The letter instructs customers to notify their customers of the recall if the product had been distributed and to return the product to Ivoclar Vivadent. For questions, please contact Ivoclar Vivadent Customer Service at 1-800-533-6825.

Device

Device Recall OptraPol Polishing Discs
  • 모델명 / 제조번호(시리얼번호)
    REF/Product ID 634459: Lot UL0843;  REF/Product ID 634458: Lot VL0704;  REF/Product ID 634464: Lot VL0705.
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of CA, FL, GA, IA, IL, IN, KS, KY, MA, MI, NV, NY, OH, PA, TX, and WA.
  • 제품 설명
    OptraPol Polishing Discs, Rx ONLY: OptraPol Refill Cup /10: REF/Product ID 634459, OptraPol Refill Small Flame/10: REF/Product ID 634458, OptraPol Assortment: REF/Product ID 634464 --Device Listing # B106952. One step polishing system for all common dental composites and amalgam.
  • Manufacturer
    Ivoclar Vivadent, Inc.

Manufacturer

Ivoclar Vivadent, Inc.