Ivoclar Vivadent, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2265-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: July 9, 2015

Date Posted: August 5, 2015

Recall Number: Z-2265-2015

Event ID: 71636

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.

Status: Terminated

Product Quantity: Domestic: 27 units

Code Information:

Batch U15124

Distribution Pattern:

US Distribution in the states of: PA, IN, IA and SC.

Voluntary or Mandated:

Voluntary: Firm initiated