Events

Rappel de BruxZir Shaded

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Prismatik Dentalcraft, Inc.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    75082
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2897-2016
  • Date de mise en oeuvre de l'événement
    2016-08-15
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149325
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Powder, porcelain - Product Code EIH
  • Cause
    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.
  • Action
    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
  • Modèle / numéro de série
    BZ0004415  BZ0004745  BZ0004416  BZ0004747  BZ0004522  BZ0004360  BZ0004496  BZ0004593  BZ0004094  BZ0004614
  • Classification du dispositif
    Dental Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
  • Description du dispositif
    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
  • Adresse du fabricant
    Prismatik Dentalcraft, Inc, 2181 Dupont Dr, Irvine CA 92612-1301
  • Société-mère du fabricant (2017)
    Prismatik Dentalcraft, Inc
  • Source
    USFDA