Sagemax NexxZr T Multi dental zirconium discs recalled for fracture risk
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.
From the FDA notice · Read the official notice ↗
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- NexxZr T Multi A3.5 W98-16mm, REF: 745451
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 113
- Illnesses reported
- None reported
- Manufactured in
- 34210 9th Ave S Ste 118, N/A, Federal Way, WA, United States
- Classification
- Class II
- Recall number
- Z-2356-2026
In the FDA's words
- Description
- NexxZr T Multi A3.5 W98-16mm, REF: 745451 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. UDI-DI: 00842271175373, Lot: YBDGLD 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. Affected quantity: 113
- 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.