FDA Medical Device Recalls (openFDA)
Sagemax Bioceramics, Inc.: NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Recall number
- Z-2356-2026
- Recalling firm
- Sagemax Bioceramics, Inc.
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Status
- Open, Classified
- Initiated
- 2025-12-11
- Posted
- 2026-06-09
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- UDI-DI: 00842271175373, Lot: YBDGLD
- 510(k) numbers
- ["K142233"]
- PMA numbers
- not on file
- Product code
- EIH
- Firm FEI
- 3007518500
- Firm city
- Federal Way
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28