NexxZr T Multi A3 — Class II medical device recall Z-2356-2026
Ongoing recall by Sagemax Bioceramics, Inc., reported 2026-06-17, distributed nationwide. Yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have reduced or missing
| Recall number | Z-2356-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sagemax Bioceramics, Inc., Federal Way, WA, United States |
| Recall initiated | 2025-12-11 |
| Classified | 2026-06-09 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Quantity | 113 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00842271175373 |
| Model numbers | 745451 |
Product
NexxZr T Multi A3.5 W98-16mm, REF: 745451
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2356-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.