FDA-Device2026-06-17Class IIPROCESSING DEFECT
Sagemax NexxZr T Multi dental zirconium discs recalled for fracture risk
Nationwide distributionMedical devices
What this means
Sagemax Bioceramics is recalling NexxZr T Multi A3.5 W98-16mm zirconium oxide discs used in dental crowns and bridges. Some discs may have a reduced or missing dentin layer, which can weaken them and cause fractures when patients chew or bite.
- If you are a dental provider with this product (Lot YBDGLD, REF 745451), contact Sagemax for instructions.
- If you had a dental crown or bridge placed with this material recently, contact your dentist to discuss whether your restoration may be affected.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
113
Manufactured in
34210 9th Ave S Ste 118, N/A, Federal Way, WA, United States
Products
NexxZr T Multi A3.5 W98-16mm, REF: 745451
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2026Want us to check the next one for you?
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