Class II — Prismatik Dentalcraft, Inc
| Recalling firm | PRISMATIK DENTALCRAFT, INC. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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. |
| Quantity | 150 units |
| Distribution | Nationwide distribution to SC, MN, NC, IN, AZ, OR, WA, CA, WY |
| Initiated | 2016-08-15 |
| Classified | 2016-09-27 |
| Terminated | 2016-12-23 |
| Recall number | Z-2897-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Prismatik Dentalcraft, Inc (Z-2897-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75082/
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