Sagemax Bioceramics, Inc. recalls NexxZr T Multi A3.5 W98-16mm

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.

On 12/11/2025, safety notices were emailed to customers who were asked to do the following: 1) Separate and block the affected device in your warehouse so that they can no longer be used. 2) Contact the recalling firm to arrange return. 3) Complete and return the response form via email to vigilance@dssm.group Queries regarding the measures described in this Field Safety Notice should be addressed to vigilance@dssm.group

• FDA enforcement recordOfficial FDA database entry for Z-2356-2026
• FDA 510(k) clearance · K142233The device's official FDA premarket clearance record
• FDA device classification · EIHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 872.6660The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Sagemax Bioceramics, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.