KeySplint Hard Clear dental devices recalled for incorrect instructions
Keystone Industries is recalling 336 units of KeySplint Hard Clear due to incorrect Instructions for Use packaged with the product. Affected units received KeySplint Soft instructions instead.
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: This is a Class II device recall due to incorrect Instructions for Use being packaged with the product. No illnesses or injuries are reported in the source text. This falls under 'minor labeling errors' per the severity rubric.
Plain-English summary
Keystone Industries is recalling 336 units of KeySplint Hard Clear in 1 kg resin bottles distributed in the United States and China. The product was inadvertently packaged with incorrect Instructions for Use—KeySplint Soft instructions were included instead of KeySplint Hard instructions.
KeySplint Hard Clear is a dental resin used to fabricate orthodontic and dental appliances, including mouthguards, nightguards, splints, repositioners, and retainers. Incorrect instructions could result in improper use of the product.
The affected lot is NB3628 (UDI: +H66842200111/$$3251116NB3628L). Consumers who have received this product should verify the instructions included match the product and contact Keystone Industries for correct instructions if needed.
The recalled product
- Product
- KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
- Manufacturer
- Keystone Industries
- Hazard
- Affected units
- 336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Distribution
Distributed nationwide across the United States.
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