Recall Z-3015-2026 ยท EBF Material, Tooth Shade, Resin
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 onl
| Date | Aug 25, 2026 (initiated Jul 9, 2026) |
| Status | Open, Classified |
| 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 |
| Action | Henry Schein issue an URGENT: MEDICAL DEVICE CORRECTION NOTIFICATION (Retail Level) notices to its consignees on 7/17/2026 via first class mail. The notices explained the issues concerning the packaging and instructions for use, risk to health, and requested the following actions be taken: (1) Review inventory to confirm if any of the affected lot numbers are in your possession. (2) If your facility has affected lots in inventory, please ensure you promptly provide the correct U.S. FDA-cleared IFU to all dental practitioners. (3) Destroy only the copies of the IFU that originally accompanie |
| Quantity | 121 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Barbados. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040769 | STRUCTUR 2 SC Voco GmbH, Apr 7, 2004 |