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Home › FDA recalls › NexxZr T Multi A3.5 W98-16mm
CLASS II · ModerateFDA

Sagemax Bioceramics, Inc. recalls NexxZr T Multi A3.5 W98-16mm

📅 Dec 11, 2025 · 📍 Nationwide
Recalling company
Sagemax Bioceramics, Inc.
Product
NexxZr T Multi A3.5 W98-16mm, REF: 745451
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.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 11, 2025
Reported
Jun 17, 2026
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.
Status
Ongoing
Quantity
113
Lot / codes
UDI-DI: 00842271175373, Lot: YBDGLD
Company location
Federal Way, WA
Recall type
Voluntary: Firm initiated
Recall number
Z-2356-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2356-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.