CLASS II Device recall · Reported 5 Oct 2016 · FDA Enforcement Report

BruxZir Shaded recalled by Prismatik Dentalcraft

Prismatik Dentalcraft is recalling BruxZir Shaded, distributed nationwide in the US. The recall was initiated on 15 Aug 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614

Quantity recalled150 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2897-2016
FDA event ID: 75082
Recalling firm: Prismatik Dentalcraft, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Aug 2016
FDA classified: 27 Sep 2016
Reported: 5 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Dental Devices

Timeline

15 Aug 2016	Recall initiated by company
27 Sep 2016	Classified by FDA	+43 days
5 Oct 2016	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY

Nationwide Arizona California Indiana Minnesota North Carolina Oregon South Carolina Washington Wyoming

Questions about this recall

Why was it recalled?

Which lots are affected?

BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614

Where was it sold?

Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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