Sagemax Bioceramics, Inc.: NexxZr T Multi A3.5 W98-16mm, REF: 745451
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Sagemax Bioceramics, Inc.
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-11
- Code info
- UDI-DI: 00842271175373, Lot: YBDGLD
- Product quantity
- 113
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Federal Way
- State
- WA
- Country
- United States
- Event id
- 98823
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