Drug recall
IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze…
FDA recall event 71636 · Class II · Ivoclar Vivadent, Inc.
Key facts
| Event ID | 71636 |
|---|---|
| Recall numbers | Z-2265-2015 |
| Recalling firm | Ivoclar Vivadent, Inc. |
| Product type | Devices |
| Products | IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray used in the fabrication of dental restorations |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Complaints were received of coarse particles in the glazed surface of IPS e.max Ceram restorations. A basic component of the glass contains a higher number of large grain sizes than usual. |
| Initiation date | Jul 9, 2015 |
| Report date | Aug 5, 2015 |
| Termination date | May 27, 2016 |
| City | Buffalo |
| State | NY |
| Country | United States |
| FEI number | 1316092 |
At a glance
- 1–9 Products in this recall
- 10–99 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: