FDA Device recall Z-2356-2026
NexxZr T Multi A3.5 W98-16mm, REF: 745451
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of NexxZr T Multi A3.5 W98-16mm, REF: 745451 by Sagemax Bioceramics, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2356-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-12-11 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Sagemax Bioceramics |
| Distribution | US |
Product
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.
Identifiers
| code_info | UDI-DI: 00842271175373, Lot: YBDGLD |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2356-2026%22
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