CLASS II ONGOING Device recall · Reported 17 Jun 2026 · FDA Enforcement Report
NexxZr T Multi A3.5 W98 recalled by Sagemax Bioceramics
Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98, distributed nationwide in the US. The recall was initiated on 11 Dec 2025 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-2356-2026
- FDA event ID
- 98823
- Recalling firm
- Sagemax Bioceramics, Federal Way, WA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2025
- FDA classified
- 9 Jun 2026
- Reported
- 17 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Dec 2025 | Recall initiated by company | |
| 9 Jun 2026 | Classified by FDA | +180 days |
| 17 Jun 2026 | 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
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Product as listed by the FDA
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Where it was distributed
Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.
Nationwide CaliforniaDelawareFloridaIdahoMinnesotaMissouriNew York
Questions about this recall
Why was it recalled?
Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing dentin layer and when used clinically in the patient's mouth there is an increased risk of fractures under functional stress.
Which lots are affected?
UDI-DI: 00842271175373, Lot: YBDGLD
Where was it sold?
Worldwide - US Nationwide distribution in the states of CA, MO, MN, NY, FL, ID and the countries of AT, CZ, DE, EE, EG, FR, GR, ID, IT, KZ, RS, SE, SI, TZ, VN.
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.
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