FDA DevicesClass II
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Published: June 17, 2026Recall ID: Z-2356-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Additional Source Details
| Field | Value |
|---|---|
| City | Federal Way |
| State | WA |
| Event id | 98823 |
| Address 1 | 34210 9th Ave S Ste 118 |
| Address 2 | N/A |
| Code info | UDI-DI: 00842271175373, Lot: YBDGLD |
| Postal code | 98003-6790 |
| Report date | 20260617 |
| Product type | Devices |
| Product quantity | 113 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251211 |
| Initial firm notification | Letter |
| Center classification date | 20260609 |
Overview
- Recalling FirmSagemax Bioceramics, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.