IPS e — Class II medical device recall Z-1705-2024
Ongoing recall by IVOCLAR VIVADENT AG, reported 2024-05-08, distributed nationwide. Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the pat
| Recall number | Z-1705-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | IVOCLAR VIVADENT AG, LIECHTSTEIN, Germany |
| Recall initiated | 2024-04-05 |
| Classified | 2024-04-30 |
| Reported by FDA | 2024-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 11,330 units |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07615208438666 |
| Lot numbers | Z063MX, Z067J9, Z067JH, Z06B6Y, Z06D4N |
Product
IPS e.max ZirCAD CER/in. Prime A2 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758438
Reason for recall
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
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-1705-2024. 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.