Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BruxZir Shaded Recalled by Prismatik Dentalcraft, Inc Due to Prismatik Dentalcraft is recalling BruxZir Shaded because the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Prismatik Dentalcraft, Inc directly.
Affected Products
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.
Quantity: 150 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Prismatik Dentalcraft, Inc
Prismatik Dentalcraft, Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report