Class IIDeviceOngoing

Henry Schein Inc.

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.

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.

Details

Recall number: Z-3015-2026
Event ID: 99465
Recall initiated: Jul 9, 2026
Classified: Aug 25, 2026
Reported: Sep 2, 2026
Quantity: 121 units
Distribution: Worldwide distribution - US Nationwide and the country of Barbados.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Denver, PA, United States
Lot / 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.