Device recall
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 1480; Lot 2539064 3) 114-3935, Mfr Product Code 1481; Lot 2533123 4) 114-3937, Mfr Product Code 1482; Lots 2533203, 2607170 is a fluorescent cold polymerizing paste-paste system for the production of temporary crowns, bridges, inlays and onlays.
- Recall number
- Z-3015-2026
- Event id
- 99465
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Henry Schein Inc.
- Report date
- Sep 2, 2026
- Posted
- Aug 25, 2026
- Initiated
- Jul 9, 2026
- Center classification date
- Aug 25, 2026
- Product code
- EBF
- Device type
- Material, Tooth Shade, Resin
- Reason
- Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
- Root cause
- Process control
- Quantity
- 121 units
- Code info
- Product Codes: 1) 114-3933, Mfr Product Code 1479, Lot Numbers: 2536179, 2606429; 2) 114-3934, Mfr Product Code 1480, Lot Numbers: 2539064; 3) 114-3935, Mfr Product Code 1481, Lot Numbers: 2533123; 4) 114-3937, Mfr Product Code 1482, Lot Numbers: 2533203, 2607170.
- Distribution
- Worldwide distribution - US Nationwide and the country of Barbados.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K040769
- Location
- Denver, PA, United States