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.
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: 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
Distribution
Related recalls
Same manufacturer · Straumann USA LLC
See all →- ModerateStraumann Recalls GM Helix Implants Due to Packaging Dimension Discrepancy
FDA (Devices) · 2026-09-23
- ModerateStraumann BLT Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2026-08-19
- ModerateStraumann Recalls GM Helix Dental Implants Due to Labeling Mismatch
FDA (Devices) · 2026-08-19
- HighStraumann n!ce Zr HT Dental Implant Abutments Recalled for Incorrect Screw Seat
FDA (Devices) · 2026-05-06
- HighStraumann n!ce PMMA Dental Implant Abutments Recalled for Screw Seat Defect
FDA (Devices) · 2026-05-06
Same hazard · mis labeling
See all →- HighBetterballen Foods Frozen Meat and Poultry Products Alerted for Undeclared Allergens
USDA FSIS · 2026-11-06
- HighEl Ruisenor De Mexico Recalls Dried Peaches for Undeclared Sulfites
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Ground Shrimp for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEl Ruisenor De Mexico Recalls Natural Sesame Seeds for Undeclared Allergen
FDA (Food) · 2026-10-28
- ModerateEvexias Amino Ultra Recalled for Undeclared Fish Oil
FDA (Food) · 2026-10-28
Similar recalls
- ModerateKeySplint Hard Clear dental devices recalled for incorrect instructions
FDA (Devices) · 2024-01-10
- HighDental implant kits recalled for mislabeled implant dimensions
FDA (Devices) · 2022-01-26
- ModerateDental implant abutments recalled for incorrect packaging labels
FDA (Devices) · 2025-03-12
- ModerateStraumann Recalls Neodent GM Mini Conical Abutments Due to Label Mismatch
FDA (Devices) · 2018-11-21
- ModerateSoft tissue anchors recalled after cartons packed with wrong device size
FDA (Devices) · 2025-10-01
- ModerateKeystone Dental Recalls Mislabeled Prima Plus Dental Implants
FDA (Devices) · 2018-06-20