# FDA recall Z-2356-2026

> **Sagemax Bioceramics, Inc.** · Class II · device recall initiated 2025-12-11.

## 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.

## 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.

## Key facts

- **Recall number:** Z-2356-2026
- **Recalling firm:** Sagemax Bioceramics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-11
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Federal Way, WA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2026

## Citation

> MORVS. FDA recall Z-2356-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2356-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*