Events

Recall of BruxZir Shaded

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Prismatik Dentalcraft, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    75082
  • Event Risk Class
    Class 2
  • Event Number
    Z-2897-2016
  • Event Initiated Date
    2016-08-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149325
  • Notes / Alerts
    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.
  • Extra notes in the data
    Powder, porcelain - Product Code EIH
  • Reason
    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
  • Model / Serial
    BZ0004415  BZ0004745  BZ0004416  BZ0004747  BZ0004522  BZ0004360  BZ0004496  BZ0004593  BZ0004094  BZ0004614
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
  • Product Description
    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
  • Manufacturer Address
    Prismatik Dentalcraft, Inc, 2181 Dupont Dr, Irvine CA 92612-1301
  • Manufacturer Parent Company (2017)
    Prismatik Dentalcraft, Inc
  • Source
    USFDA