Date Initiated by Firm |
July 09, 2015 |
Date Posted |
July 27, 2015 |
Recall Status1 |
Terminated 3 on May 27, 2016 |
Recall Number |
Z-2265-2015 |
Recall Event ID |
71636 |
510(K)Number |
K012174
|
Product Classification |
Powder, porcelain - Product Code EIH
|
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 |
Code Information |
Batch U15124 |
Recalling Firm/ Manufacturer |
Ivoclar Vivadent, Inc. 175 Pineview Dr Buffalo NY 14228-2231
|
For Additional Information Contact |
Donna Marie Hartnett, Esq. 716-691-2260
|
Manufacturer 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.
|
FDA Determined Cause 2 |
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 in Commerce |
Domestic: 27 units |
Distribution |
US Distribution in the states of: PA, IN, IA and SC. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = EIH and Original Applicant = IVOCLAR NORTH AMERICA, INC.
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