Recall Z-2897-2016— Prismatik Dentalcraft, Inc

Name: FDA recall Z-2897-2016
Creator: U.S. Food and Drug Administration
Published: 2016-08-15

Class II · Terminated

Class II FDA medical device recall by Prismatik Dentalcraft, Inc, initiated 2016-08-15, terminated 2016-12-23. It names one FDA 510(k) clearance: K130924. Product: 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.. 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..

Recalling firm: Prismatik Dentalcraft, Inc
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Terminated: 2016-12-23
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K130924 — BRUXZIR SHADEDPrismatik Dentalcraft, Inc.·cleared 2013-05-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.