FDA Device recall Z-1706-2024
IPS e.max ZirCAD CER/in
- FDA Device
- Class II
- ongoing
- Published 2024-05-08
On 2024-05-08 the FDA classified a Class II recall of IPS e.max ZirCAD CER/in by Ivoclar Vivadent Ag, citing defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1706-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-04-05 |
| Published | 2024-05-08 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ivoclar Vivadent Ag |
| Distribution | US |
Product
IPS e.max ZirCAD CER/in. Prime A3 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth Article Number: 758439
Reason
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Identifiers
| code_info | UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439…UDI-DI: (01)07615208438659 (11)231117 (10)Z063MT (241)758439; (01)07615208438659 (11)231214 (10)Z067JF (241)758439; (01)07615208438659 (11)231214 (10)Z067JC (241)758439; (01)07615208438659 (11)231214 (10)Z067JG (241)758439; (01)07615208438659 (11)231214 (10)Z067JB (241)758439; (01)07615208438659 (11)240105 (10)Z06B6Z (241)758439; (01)07615208438659 (11)240112 (10)Z06CBG (241)758439 Batch No. Z063MT, Z067JF, Z067JC, Z067JG, Z067JB, Z06B6Z, Z06CBG |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1706-2024%22
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