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Open, Classified

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

FDA Recall Z-2356-2026 · Posted 2026-06-09

Recalling FirmSagemax Bioceramics, Inc.
Recall StatusOpen, Classified
Product CodeEIH
Date Initiated2025-12-11
Product Quantity113

Reason for Recall

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.

Firm Action

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 [email protected] Queries regarding the measures described in this Field Safety Notice should be addressed to [email protected]

Root Cause

Process control

Distribution Pattern

Worldwide - US Nationwide distribution in the states of 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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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