Z-3016-2026 Class II Ongoing
FDA device recall Z-3016-2026 was initiated by Henry Schein Inc. on July 9, 2026 and is designated Class II. Reason for recall: Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. The recall status is ongoing. Affected quantity: 853 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 2, 2026
- Initiation Date
- July 9, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 853 units
Product Description
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 for Recall
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Barbados.
Code Information
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.