FDA Posts Class 2 Recall for Sagemax NexxZr Zirconia Discs Over Fracture Risk

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Posted: June 10, 2026

FDA Posts Class 2 Recall for Sagemax NexxZr Zirconia Discs Over Fracture Risk

Edited by Dentaltown staff

The U.S. Food and Drug Administration has posted an open Class 2 recall for a Sagemax Bioceramics zirconia disc used to fabricate fixed all-ceramic restorations, after the manufacturer determined the discs may have a reduced or missing dentin layer that increases the risk of fracture under functional stress once placed in the patient’s mouth.

The recall, posted June 9, covers the NexxZr T Multi A3.5 W98-16mm disc (REF 745451, lot YBDGLD) and carries recall number Z-2356-2026. The product is a yttrium-stabilized zirconium oxide disc cleared under 510(k) K142233. The FDA listed the cause as a process control issue and classified the recall as open, meaning corrective action is still underway.

Sagemax initiated the action on Dec. 11, 2025, emailing safety notices to affected customers. Recipients were instructed to separate and block the affected discs in their inventory so they could no longer be used, to contact the firm to arrange a return, and to complete and return a response form. Questions about the field safety notice were directed to the firm at vigilance@dssm.group.

The recall covers 113 units in commerce. The affected discs were distributed to customers in six U.S. states, California, Missouri, Minnesota, New York, Florida, and Idaho, and in 15 other countries across Europe, Asia, Africa, and Central Asia.

The recalling firm, Sagemax Bioceramics, Inc., is based in Federal Way, Washington. Practitioners and laboratories with questions about affected inventory can reach the company at the contact listed in the FDA recall record.

Because the recall remains open and classified, the FDA record notes it will be updated as the manufacturer’s corrective action progresses and again if the recall is terminated.

Sources:
U.S. Food and Drug Administration, “Class 2 Device Recall: NexxZr T Multi A3.5 W98-16mm,” Sagemax Bioceramics, Inc., recall number Z-2356-2026, posted June 9, 2026: accessdata.fda.gov/recall/219890



FDA Posts Class 2 Recall for Sagemax NexxZr Zirconia Discs Over Fracture Risk

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