NexxZr T Multi A3.5 W98-16mm recall (Sagemax Bioceramics, Inc.)
Medical deviceClass IIOngoing
Summary: Sagemax Bioceramics, Inc. is recalling NexxZr T Multi A3.5 W98-16mm, REF: 745451. Reason: 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 is being recalled
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was 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. (states named: California, Florida, Idaho, Minnesota, Missouri, New York)
How to tell if yours is affected
UDI-DI: 00842271175373, Lot: YBDGLD
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2356-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | December 11, 2025 |
| Reported | June 17, 2026 |
| Company | Sagemax Bioceramics, Inc. |
| Company location | Federal Way, WA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 113 |
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