Z-2356-2026Class II

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

Name: Z-2356-2026 NexxZr T Multi A3.5 W98-16mm, REF: 745451
Creator: Sagemax Bioceramics, Inc.
Published: 2025-12-11
License: https://open.fda.gov/license/

Sagemax Bioceramics, Inc. / initiated 2025-12-11 / Open, Classified / root cause: manufacturing process

FDA source

Sagemax Bioceramics, Inc. began a recall of NexxZr T Multi A3.5 W98-16mm, REF: 745451 on 2025-12-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2356-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-11
Posted: 2026-06-09
Recalling firm: Sagemax Bioceramics, Inc.
Product: NexxZr T Multi A3.5 W98-16mm, REF: 745451
Product code: EIH Powder, Porcelain
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.
Root cause tag: manufacturing process
FDA 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 [email protected] Queries regarding the measures described in this Field Safety Notice should be addressed to [email protected]
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 00842271175373, Lot: YBDGLD

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2356-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2356-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-09

Product code EIH

K142233Class IIzenostar MO, Zenostar T, Zenostar VisualiZrWieland Dental + Technik GmbH & Co. KG / cleared 2015-01-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)