Device Recall IPS Empress Universal Glaze Spray 의 리콜

Recall

71636

Class 2

Z-2265-2015

2015-07-09

2015-07-27

Terminated

United States

2016-05-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138435

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.

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.