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U.S. Department of Health and Human Services

Class 2 Device Recall NexxZr T Multi A3.5 W9816mm

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 Class 2 Device Recall NexxZr T Multi A3.5 W9816mmsee related information
Date Initiated by FirmDecember 11, 2025
Date PostedJune 09, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2356-2026
Recall Event ID 98823
510(K)NumberK142233 
Product Classification Powder, porcelain - Product Code EIH
ProductNexxZr T Multi A3.5 W98-16mm, REF: 745451
Code Information UDI-DI: 00842271175373, Lot: YBDGLD
FEI Number 3007518500
Recalling Firm/
Manufacturer		 Sagemax Bioceramics, Inc.
34210 9th Ave S Ste 118
Federal Way WA 98003-6790
For Additional Information ContactLucina Celetse
732-357-8135
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionOn 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 in Commerce113
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = EIH
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