Events

BruxZir Shaded 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Prismatik Dentalcraft, 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
    75082
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2897-2016
  • 사례 시작날짜
    2016-08-15
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-12-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149325
  • 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
    Powder, porcelain - Product Code EIH
  • 원인
    Prismatik dentalcraft is recalling bruxzir shaded because the new design was manufactured at risk and were to be quarantined and held until the validation was completed. prismatik failed to properly identify the lots as quarantined product.
  • 조치
    Prismatik DentalCraft, Inc. sent an Urgent Medical Device Recall letter dated August 15, 2016, to all their customers to inform them that Prismatik Dentalcraft is recalling BruxZir NOW product because the new design was manufactured at risk and was supposed to be quarantined and held until validation was completed. Prismatik failed to properly identify the implicated lots as quarantined product. Customers are informed that the BruxZir Now with the thicker sprue design was packaged and shipped to customers in error. Customers are informed of that there is no risk to the patient and of the actions to be taken for the customers and from Prismatic Dentalcraft Inc. For questions regarding this recall call 949-440-2600.

Device

BruxZir Shaded
  • 모델명 / 제조번호(시리얼번호)
    BZ0004415  BZ0004745  BZ0004416  BZ0004747  BZ0004522  BZ0004360  BZ0004496  BZ0004593  BZ0004094  BZ0004614
  • 의료기기 분류등급
    Dental Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
  • 제품 설명
    BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 || The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.
  • Manufacturer
    Prismatik Dentalcraft, Inc

Manufacturer

Prismatik Dentalcraft, Inc
  • 제조사 주소
    Prismatik Dentalcraft, Inc, 2181 Dupont Dr, Irvine CA 92612-1301
  • 제조사 모회사 (2017)
    Prismatik Dentalcraft, Inc
  • Source
    USFDA