Class II — Sagemax Bioceramics, Inc.
| Recalling firm | SAGEMAX BIOCERAMICS, INC. |
|---|---|
| Registered facility | SAGEMAX BIOCERAMICS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | NexxZr T Multi A3.5 W98-16mm, REF: 745451 |
| Quantity | 113 |
| Distribution | 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. |
| Initiated | 2025-12-11 |
| Classified | 2026-06-09 |
| Recall number | Z-2356-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Sagemax Bioceramics, Inc. (Z-2356-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98823/
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