CLASS II ONGOING Device recall · Reported 8 May 2024 · FDA Enforcement Report
IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag
Ivoclar Vivadent is recalling IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of, distributed nationwide in the US. The recall was initiated on 5 Apr 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1707-2024
- FDA event ID
- 94401
- Recalling firm
- Ivoclar Vivadent, LIECHTSTEIN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Apr 2024
- FDA classified
- 30 Apr 2024
- Reported
- 8 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 5 Apr 2024 | Recall initiated by company | |
| 30 Apr 2024 | Classified by FDA | +25 days |
| 8 May 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IPS e.max ZirCAD CER/in. Prime B1 C17/5 -A zirconium oxide block for the fabrication of fixed, full-contour restorations in anterior and posterior teeth. Article Number: 758441
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient's mouth and require restoration
Which lots are affected?
UDI-DI: (01)07615208438635 (11)231130 (10)Z065M0 (241)758441; (01)07615208438635 (11)240112 (10)Z06CBH (241)758441 Batch No. Z065M0, Z06CBH
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 94401This product is part of a recall event; the main page for the event is IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide | |
| CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide | |
| CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide | |
| CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide | |
| CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
More recalls from Ivoclar Vivadent
All 44| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent | Device Malfunction | Nationwide |
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