CLASS II Device recall · Reported 13 May 2020 · FDA Enforcement Report
IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic recalled
Ivoclar Vivadent AG is recalling Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, distributed nationwide in the US. The recall was initiated on 13 Apr 2020 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-1839-2020
- FDA event ID
- 85450
- Recalling firm
- Ivoclar Vivadent AG, Schaan, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Apr 2020
- FDA classified
- 1 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Dental Devices
Timeline
| 13 Apr 2020 | Recall initiated by company | |
| 1 May 2020 | Classified by FDA | +18 days |
| 13 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Restorations crack during the sintering process.
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
Ivoclar Vivadent IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max ZirCAD presintered yttrium oxide-stabilized zirconium oxide blocks for the CAD/ CAM technology Product Number: 686195
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max recalled?
Yes. Ivoclar Vivadent AG recalled IPS e.max ZirCAD CER/inLab LT A3 C17/5 - ceramic for dental use, intended for IPS e.max on 13 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-1839-2020.
Why was it recalled?
Restorations crack during the sintering process.
Which lots are affected?
Lot Numbers: Y38637, Y47754, Y52136
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ivoclar Vivadent AG
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent Ag | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent Ag | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent Ag | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent Ag | Device Malfunction | Nationwide |
| Device | CLASS II | IPS e.max ZirCAD CER/in recalled by Ivoclar Vivadent Ag | Ivoclar Vivadent Ag | Device Malfunction | Nationwide |
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|---|---|---|---|---|---|
| Device | CLASS II | Grandio Universal Nano-Hybrid Restorative Material recalled | Henry Schein | Packaging Defects | Nationwide |
| Device | CLASS II | GM Helix Implant, Endosseous Dental Implant Article No. recalled | Straumann USA | Packaging Defects | Nationwide |
| Device | CLASS II | KL Owen Custom Orthodontic Solution recalled by Klowen Braces | Klowen Braces | Device Malfunction | Nationwide |
| Device | CLASS II | Straumann n!ce PMMA Full-arch Restoration recalled | Straumann USA | Other | 8 states |
| Device | CLASS II | Straumann n!ce Zr, HT, Full-arch Restoration recalled | Straumann USA | Other | 8 states |