Recall Z-2265-2015 ยท EIH Powder, Porcelain
Ivoclar Vivadent, Inc.
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
| Date | Jul 27, 2015 (initiated Jul 9, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | Ivoclar Vivadent sent an URGENT MEDICAL DEVICE RECALL Letter (dated 7/8/2015) and Response Form to affected customers via Certified Mail Return Receipt Request. The letter identified the affected product, problem and actions to be taken. Customers were instructed to notify dentists of the recall and request return of product. A notification letter was sent to dentists on 7/24/2015 requesting they destroy the product on hand (if any) and report back to Ivoclar Vivodent. For questions in the United States contact US Headquarters Ivoclar Vivadent Customer Services at 1-800-533-6825. |
| Quantity | Domestic: 27 units |
| Distribution | US Distribution in the states of: PA, IN, IA and SC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012174 | ERIS LAYERING MATERIALS Ivoclar North America, Inc., Aug 27, 2001 |