Henry Schein Inc.: Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 25
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Henry Schein Inc.
- Product
- Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-3595, Mfr Product Code 1841; Lots 2539075, 2539313, 2609789, 2539065 3) 949-3596, Mfr Product Code 1842; Lots 2536632, 2609174, 2610099 4) 949-3597, Mfr Product Code 1843; Lots 2535296, 2537418, 2607283 is a light-cured, nano-hybrid dental composite restorative material intended for direct restorative procedures.
- Reason / hazard
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the country of Barbados.
- Recall initiated
- 2026-07-09
- Code info
- Product Codes: 1) 949-3594, Mfr Product Code 1840, Lot Numbers: 2529604, 2538147, 2608145; 2) 949-3595, Mfr Product Code 1841, Lot Numbers: 2539075, 2539313, 2609789, 2539065; 3) 949-3596, Mfr Product Code 1842, Lot Numbers: 2536632, 2609174, 2610099; 4) 949-3597, Mfr Product Code 1843, Lot Numbers: 2535296, 2537418, 2607283.
- Product quantity
- 853 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Denver
- State
- PA
- Country
- United States
- Event id
- 99465
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