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.
FDA Recall Z-3015-2026 · Posted 2026-08-25
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Recalling FirmHenry Schein Inc.
Recall StatusOpen, Classified
Product CodeEBF
Date Initiated2026-07-09
Product Quantity121 units
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.
Firm 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 accompanied the affected lot numbers.
(4) Please complete, sign, date, and return the enclosed Henry Schein Response Form within thirty (30) calendar days of receipt to [email protected].
OTHER INFORMATION: If you have any further questions regarding this matter, please contact Henry Schein Customer Service at 1-800-472-4346.
Root Cause
Process control
Distribution Pattern
Worldwide distribution - US Nationwide and the country of Barbados.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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