Ivoclar Vivadent, Inc. recalls IPS Empress Universal Glaze Spray 270 mL, Product Code/Model/Catalog Number 609432AN, Rx only. Porcelain glaze spray us…
- Recall date
- July 9, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2265-2015
- FDA classification
- Class II
- Brand / firm
- Ivoclar Vivadent, Inc.
- Sold / distributed
- US Distribution in the states of: PA, IN, IA and SC.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
Get recall alerts
Free email alert whenever Ivoclar Vivadent, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Ivoclar Vivadent, Inc.