Virtual XD Test Pack Heavy/Light Fast Set — Class II medical device recall Z-0719-2017
Terminated recall by Ivoclar Vivadent, Inc., reported 2016-12-14, distributed nationwide. The firm received complaints claiming the dental material failed to set up. As the dental material ages, the s
| Recall number | Z-0719-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent, Inc., Amherst, NY, United States |
| Recall initiated | 2016-11-09 |
| Classified | 2016-12-07 |
| Reported by FDA | 2016-12-14 |
| Terminated | 2018-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Lot numbers | TL4094, TL4095 |
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 for recall
The firm received complaints claiming the dental material failed to set up. As the dental material ages, the set time may increase.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0719-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.