FDAFDA · Food and drugs·Recall number Z-2356-2026
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Published June 17, 2026 · Recall initiated: December 11, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Sagemax Bioceramics, Inc.
- Distributor
- 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.
- Lot
- UDI-DI: 00842271175373, Lot: YBDGLD
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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