NexxZr T Multi A3.5 W98-16mm, REF: 745451 recallZ-2356-2026 · Sagemax Bioceramics, Inc. · initiated Dec 11, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sagemax Bioceramics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Process control
What the company is doing
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]
Recall details
- Recall number
- Z-2356-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 11, 2025
- Posted by the FDA
- Jun 9, 2026
- Recalling firm
- Sagemax Bioceramics, Inc.
- Quantity
- 113
- Product code
- EIH
- FDA submissions
- K142233
- 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.
Product description
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Code information (models, lots, serial numbers)
UDI-DI: 00842271175373, Lot: YBDGLD
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NexxZr® T Multi / W-98-16-NT-A350-MT 745451Sagemax Bioceramics, Inc · Powder, Porcelain1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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