Z-2356-2026 Class II Ongoing

Recalled by Sagemax Bioceramics, Inc. — Federal Way, WA

Recall Details

Product Type
Devices
Report Date
June 17, 2026
Initiation Date
December 11, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
113

Product Description

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 Pattern

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.

Code Information

UDI-DI: 00842271175373, Lot: YBDGLD