BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2265-2015 · Initiated July 9, 2015

    Recall

    Recall Number
    Z-2265-2015
    Event Number
    71636
    Firm
    Ivoclar Vivadent, Inc.
    FEI Number
    1316092
    Product Code
    EIH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 9, 2015
    Posted
    July 27, 2015
    Terminated
    May 27, 2016
    Address
    175 Pineview Dr, Buffalo, NY, 14228-2231

    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

    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.

    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.

    Distribution

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

    Quantity

    Domestic: 27 units