Drug recall
BruxZir Shaded, Model No. 70-1167-NOW0001, 70-1167-NOW0002, 70-1167-NOW0003, 70-1167-NOW0005, 70-1167-NOW0006…
FDA recall event 75082 · Class II · Prismatik Dentalcraft, Inc
Key facts
| Event ID | 75082 |
|---|---|
| Recall numbers | Z-2897-2016 |
| Recalling firm | Prismatik Dentalcraft, Inc |
| Product type | Devices |
| 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Aug 15, 2016 |
| Report date | Oct 5, 2016 |
| Termination date | Dec 23, 2016 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 3002195199 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: