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Recall Observatory FDA recall evidence

Device product

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

Z-2265-2015

July 09, 2015

Class II

Product summary

Firm
Ivoclar Vivadent, Inc.
Event
Event 71636
Status
Terminated
Classification
Class II
Quantity
Domestic: 27 units
Official record key
device-enforcement:Z-2265-2015

Official wording

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.

Code information: Batch U15124

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.