FDA-Device2026-09-02Class IIMISBRANDING
Henry Schein Structur 2 SC Temporary Resin recalled for incorrect packaging and instructions
What this means
Specific lots of Henry Schein Structur 2 SC Temporary Resin Cartridge Refill were distributed with incorrect packaging and instructions for use. This dental material is used to make temporary crowns, bridges, inlays, and onlays. The incorrect instructions could affect proper use of the product.
- Check if you have one of the affected product codes (114-3933, 114-3934, 114-3935, or 114-3937) and lot numbers listed in the recall notice
- Do not use affected lots; contact Henry Schein for a replacement with correct packaging and instructions
- Verify the correct instructions before using any replacement product
The agency's original wording
Hazard
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Barbados.
Affected count
121 units
Manufactured in
41 Weaver Rd, N/A, Denver, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3015-2026Want us to check the next one for you?
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