FDAHealthDecember 11, 2025
Sagemax Bioceramics, Inc. — NexxZr T Multi A3.5 W98-16mm, REF: 745451
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 11, 2025
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's affected?
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Lot code
- YBDGLD
Additional details
UDI-DI: 00842271175373, Lot: YBDGLD
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 113.
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