Z-3015-2026 Class II Ongoing
FDA device recall Z-3015-2026 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: 121 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
- 121 units
Product Description
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Barbados.
Code Information
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.