FDA recall Z-2356-2026

Sagemax Bioceramics, Inc. · Class II · device

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

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

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