KeyPrint Soft Dental Resin Recalled for Incorrect European Labeling
Straumann USA LLC recalled KeyPrint Soft resin bottles (Lot KJ2858) that were distributed with European product labels instead of US-compliant labeling. Dental professionals should verify if they received affected units.
What this means for you
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: FDA Class II recall with a labeling non-compliance—European product labels were distributed instead of US-required labeling. No injuries or illnesses have been reported. This falls under 'minor labeling errors' in the severity rubric.
Plain-English summary
Straumann USA LLC is recalling KeyPrint Soft resin bottles (32.5 oz, Model 4220005, Lot KJ2858) distributed with European product labeling. The product was distributed nationwide in Texas.
The resin is used by dental professionals to fabricate orthodontic and dental appliances including mouthguards, nightguards, splints, and repositioners. Instead of required US labeling, affected units were distributed with product labels intended for the European market.
Dental professionals and organizations in the US who may have received this product should verify whether they have units from Lot KJ2858 with European labeling. Contact Straumann USA LLC for assistance with identifying affected stock or obtaining replacement units with proper US labeling.
The recalled product
- Product
- KeyPrint Soft- bottle, 32.5 oz (1kg). Resin for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints and repositioners. Model (Ref) #: 4220005
- Manufacturer
- Straumann USA LLC
- Hazard
- mis-labeling
Distribution
Distributed nationwide across the United States.
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