NexxZr T Multi Dental Discs Recall

Source: FDA · Worldwide

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Sagemax Bioceramics, Inc. is recalling 113 units of NexxZr T Multi A3.5 W98-16mm discs due to potential reduced or missing dentin layer increasing fracture risk.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on July 28, 2026 and geographically references Worldwide. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.

What Happened

Sagemax Bioceramics, Inc. initiated a voluntary recall of yttrium-stabilized zirconium oxide discs for fixed all-ceramic dental restorations. The products may have a reduced or missing dentin layer, which can increase the risk of fractures under functional stress when used in a patient's mouth.

Which Products Are Affected

NexxZr T Multi A3.5 W98-16mm, REF: 745451. UDI-DI: 00842271175373, Lot: YBDGLD. A total of 113 units are affected. Distribution includes US nationwide in 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. Recall number: Z-2356-2026. Classification: Class II.

What You Should Do

No specific consumer action steps are provided in the recall notice.

Why This Matters

The recall addresses a defect that may lead to fractures in dental restorations under functional stress.

Source

FDA recall Z-2356-2026, report date 20260617.

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Sagemax Bioceramics, Inc. is recalling 113 units of NexxZr T Multi A3.5 W98-16mm discs due to potential reduced or missing dentin layer increasing fracture risk.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects Worldwide. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.