[pending] NexxZr T Multi A3.5 W98-16mm, REF: 745451
Pending LLM rewrite. Source: FDA_DEVICE Z-2356-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Manufacturer
- Sagemax Bioceramics, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI-DI: 00842271175373
- Lot: YBDGLD
Distribution
Distributed nationwide across the United States.
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