Henry Schein Recalls Structur 2 SC Temporary Resin Cartridges for Incorrect Packaging
Henry Schein Inc. is recalling specific lots of Structur 2 SC Temporary Resin Cartridge Refills because they were distributed with incorrect packaging and Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the specific hazard is incorrect packaging and Instructions for Use, which aligns with the rubric criterion for minor labeling errors and documentation issues.
Plain-English summary
Henry Schein Inc. is recalling 121 units of Structur 2 SC Temporary Resin Cartridge Refill 75Gm. The affected product is a fluorescent cold polymerizing paste-paste system used for the production of temporary crowns, bridges, inlays, and onlays.
The recall was initiated because specific lots were distributed in the United States with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device. The affected product codes and lot numbers are: 114-3933 (Lots 2536179, 2606429), 114-3934 (Lot 2539064), 114-3935 (Lot 2533123), and 114-3937 (Lots 2533203, 2607170).
The product was distributed nationwide in the US and in Barbados. Healthcare professionals and consumers should check their inventory for these specific product codes and lot numbers. If found, the product should be removed from use and returned to the distributor or manufacturer for credit or replacement.
The recalled product
- Product
- 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…
- Manufacturer
- Henry Schein Inc.
- Affected units
- 121
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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.
Distribution
Distributed nationwide across the United States.
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