Recall Z-0719-2017 ยท ELW Material, Impression
Ivoclar Vivadent, Inc.
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
| Date | Nov 9, 2016 |
| Status | Terminated |
| Reason | The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase. |
| Root cause | Under Investigation by firm |
| Action | Ivoclar Vivadent sent and URGENT - MEDICAL DEVICE RECALL Letters (dated 11/07/2016) and Recall Response Forms to customers via Certified Mail-Return Receipt Requested. The letter identified the affected product, problem and actions to be taken. Customers were advised to return all affected products in stock. For questions contact Ivoclar Vivadent Customer Service at 800-533-6825. |
| Quantity | US: 2090 units, Canada: 331 units, Australia: 465 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Canada and Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083739 | HYDRORISE AND HYDROSYSTEM Zhermack S.P.A., Mar 26, 2009 |