Z-2897-2016Class II

BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006...

Name: Z-2897-2016 BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006...
Creator: Prismatik Dentalcraft, Inc
Published: 2016-08-15
License: https://open.fda.gov/license/

Prismatik Dentalcraft, Inc. / initiated 2016-08-15 / Terminated / root cause: manufacturing process

FDA source

Prismatik Dentalcraft, Inc began a recall of 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... on 2016-08-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2897-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-15
Posted: 2016-09-27
Terminated: 2016-12-23
Recalling firm: Prismatik Dentalcraft, Inc.
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.
Product code: EIH Powder, Porcelain
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.
Root cause tag: manufacturing process
FDA root cause: Release of Material/Component prior to receiving test results
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.
Quantity in commerce: 150 units
Distribution: Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY
Product codes and lots: BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2897-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2897-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code EIH

K130924Class IIBruxzir ShadedPrismatik Dentalcraft, Inc. / cleared 2013-05-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)