Recall Z-2356-2026 ยท EIH Powder, Porcelain
Sagemax Bioceramics, Inc.
NexxZr T Multi A3.5 W98-16mm, REF: 745451
| Date | Jun 9, 2026 (initiated Dec 11, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| 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 vigilance@dssm.group Queries regarding the measures described in this Field Safety Notice should be addressed to vigilance@dssm.group |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr Wieland Dental + Technik GmbH & Co. KG, Jan 5, 2015 |