Medical Device Recall: NexxZr T Multi A3.5 W98-16mm, REF: 745451
Sagemax Bioceramics, Inc. · December 11, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
113
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2356-2026
Status: ongoing
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