Skip to content
Recall Observatory FDA recall evidence

Device product

NexxZr T Multi A3.5 W98-16mm, REF: 745451

Z-2356-2026

December 11, 2025

Class II

Product summary

Firm
Sagemax Bioceramics, Inc.
Event
Event 98823
Status
Ongoing
Classification
Class II
Quantity
113
Official record key
device-enforcement:Z-2356-2026

Official wording

Reason: 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.

Code information: UDI-DI: 00842271175373, Lot: YBDGLD

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.

Field note

Send feedback

We'll only use this to respond to your feedback.