FDA Device recall Z-0719-2017
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
- FDA Device
- Class II
- terminated
- Published 2016-12-14
On 2016-12-14 the FDA classified a Class II recall of Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material by Ivoclar Vivadent, citing the firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0719-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-11-09 |
| Published | 2016-12-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ivoclar Vivadent |
| Distribution | US |
Product
Virtual XD Test Pack Heavy/Light Fast Set, 2 x 50 ml, REF #/Product Code 646469, Rx ONLY -- Product Usage: Dental impression material
Reason
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Identifiers
| code_info | Lot No./Expiration Date: TL4095/Jan 15, 2017; TL4094/Jan 15, 2017 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0719-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.