The Recall Desk
HighFDA (Devices)·Z-2356-2026·Announced 2026-06-17

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.

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: 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.
Category
Medical Device — Dental restoration material
Hazard
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

Distributed nationwide across the United States.

The notice also names 7 states specifically:

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