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
Reported: August 5, 2015 Initiated: July 9, 2015 #Z-2265-2015
Product Description
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
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.
Details
- Recalling Firm
- Ivoclar Vivadent, Inc.
- Units Affected
- Domestic: 27 units
- Distribution
- US Distribution in the states of: PA, IN, IA and SC.
- Location
- Buffalo, NY
Frequently Asked Questions
What product 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. Recalled by Ivoclar Vivadent, Inc.. Units affected: Domestic: 27 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2015. Severity: Moderate. Recall number: Z-2265-2015.
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