BruxZir Shaded — Class II medical device recall Z-2897-2016
Terminated recall by Prismatik Dentalcraft, Inc, reported 2016-10-05, distributed nationwide. Prismatik Dentalcraft is recalling BruxZir Shaded because the new design was manufactured at risk and were to
| Recall number | Z-2897-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Prismatik Dentalcraft, Inc, Irvine, CA, United States |
| Recall initiated | 2016-08-15 |
| Classified | 2016-09-27 |
| Reported by FDA | 2016-10-05 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 150 units |
| Model numbers | 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2897-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.