NexxZr dental zirconia discs may have reduced or missing dentin layer
NexxZr T Multi A3.5 zirconia discs for all-ceramic dental restorations are being recalled because a reduced or missing dentin layer increases the risk of fracture in the mouth.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with a stated increased risk of restoration fracture in the patient's mouth, a risk of harm with no injuries reported.
Plain-English summary
The NexxZr T Multi A3.5 W98-16mm disc, REF 745451, UDI-DI 00842271175373, is being recalled. The action covers 113 units in lot YBDGLD.
The stated reason is that yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations may have a 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 FDA classified the action as Class II.
Distribution was worldwide, including within the United States in California, Missouri, Minnesota, New York, Florida and Idaho. The discs are supplied to dental laboratories rather than sold to consumers.
Laboratories should identify affected stock using the REF, UDI-DI and lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Manufacturer
- Sagemax Bioceramics, Inc.
- Affected units
- 113
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
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