FDA Medical devices recall ·
NexxZr T Multi A3.5 W98-16mm recall
- Recall number
- Z-2356-2026
- Date
- (initiated December 11, 2025)
- Company / brand
- Sagemax Bioceramics, Inc.
34210 9th Ave S Ste 118, Federal Way, WA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 113
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI: 00842271175373, Lot: YBDGLD
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.
States: California Delaware Florida Idaho Minnesota Missouri New York
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2356-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.