FDA recall, , Moderate risk
Sagemax Bioceramics NexxZr T Multi Dental Zirconia
NexxZr T Multi A3.5 W98-16mm dental discs may have a reduced or missing dentin layer, increasing fracture risk under stress.
Summary by Recall Canary from the FDA notice
What happened
Sagemax Bioceramics, Inc., of Federal Way, Washington, began a recall on December 11, 2025, of NexxZr T Multi A3.5 W98-16mm, REF: 745451, yttrium-stabilized zirconium oxide discs used for fixed all-ceramic dental restorations. The discs may have a reduced or missing dentin layer, which increases the risk of fractures under functional stress when used in a patient's mouth.
The FDA added the recall to its Enforcement Report and classified it on June 9, 2026. Distribution included U.S. states California, Delaware, Florida, Idaho, Minnesota, Missouri, and New York, and worldwide countries as listed in the report.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
NexxZr T Multi A3.5 W98-16mm
- UDI-DI
- 00842271175373
- Reference number
- 745451
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution in the states of California, Missouri, Minnesota, New York, Florida, Idaho and the countries of AT, CZ, Delaware, EE, EG, FR, GR, Idaho, IT, KZ, RS, SE, SI, TZ, VN.
- Company
- Sagemax Bioceramics, Inc.Federal Way, Washington
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98823
- Recall number
- Z-2356-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
