Reported Jun 17, 2026 · Ongoing

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

Sagemax Bioceramics, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Sagemax Bioceramics, Inc. · 34210 9th Ave S Ste 118 · Federal Way, WA · 98003-6790

Is this the product you have?

  • NexxZr T Multi A3.5 W98-16mm
  • REF745451
Lot codes and dates
  • UDI-DI00842271175373
  • LotYBDGLD
Amount recalled
113

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 3:26 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.