Recalling firm
Sagemax Bioceramics, Inc.
Product type
Device
Status
Ongoing
Report date
2026-06-17
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.
Firm state
WA
Product quantity
113
Initiated by
Voluntary: Firm initiated
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.
Product description
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Code / lot info
UDI-DI: 00842271175373, Lot: YBDGLD
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.