Ivoclar Vivadent IPS e — Class II medical device recall Z-1840-2020
Terminated recall by Ivoclar Vivadent AG, reported 2020-05-13, distributed nationwide. Restorations crack during the sintering process.
| Recall number | Z-1840-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ivoclar Vivadent AG, Schaan, N/A, Liechtenstein |
| Recall initiated | 2020-04-13 |
| Classified | 2020-05-01 |
| Reported by FDA | 2020-05-13 |
| Terminated | 2021-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 6 units |
| Reason classes | packaging |
| Lot numbers | Y49356, Z0007Z, Z000KK, Z006HV |
Product
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab Start.Kit LT - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686282EN
Reason for recall
Restorations crack during the sintering process.
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-1840-2020. 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.