FDA Device recall Z-2897-2016
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006 The device is indicated for u…
- FDA Device
- Class II
- terminated
- Published 2016-10-05
On 2016-10-05 the FDA classified a Class II 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 u… by Prismatik Dentalcraft, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2897-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-15 |
| Published | 2016-10-05 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Prismatik Dentalcraft |
| Distribution | US |
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
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.
Identifiers
| code_info | BZ0004415 BZ0004745 BZ0004416 BZ0004747 BZ0004522 BZ0004360 BZ0004496 BZ0004593 BZ0004094 BZ0004614 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2897-2016%22
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