NexxZr T Multi A3.5 W98-16mm, REF: 745451
FDA device recall Z-2356-2026 · posted 2026-06-09 · Open, Classified
Recall details
- Recalling firm
- Sagemax Bioceramics, Inc.
- 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.
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- EIH
- Quantity affected
- 113
- Distribution
- 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.
- Date initiated
- 2025-12-11
- Date posted
- 2026-06-09
- Location
- Federal Way, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| zenostar MO, Zenostar T, Zenostar VisualiZr (K142233) | Wieland Dental + Technik GmbH & Co. KG | 2015-01-05 |