HIGHRegulatoryTier 1
FDA Class II recall: Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 18…
Summary & scoring by The Bell Brief (Dr. Jennifer Bell) using the Drill-Down Protocol (Drill-Down Score) — not the original publisher.
Why it matters for dental
Dental practices using Grandio Universal Nano-Hybrid Restorative in capsules risk incorrect handling instructions or mis-labeled contents, triggering a Class II recall that affects direct-restorative procedures and patient outcomes.
Key points
- Recall Z-3016-2026 covers specific lots of capsules (product codes 949-3594 and 18-…) distributed nationwide and in Barbados.
- Henry Schein Inc. states the affected units were shipped with packaging and IFU that do not match the FDA-cleared labeling.
- Class II designation means potential temporary or reversible adverse health consequences, including improper curing or placement technique.
- Clinics should immediately quarantine the listed lots and contact Henry Schein for corrected product and updated IFU.
Who should care
OwnerAssociateStaff
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