Keystone Industries is recalling 336 units of Keyprint KeySplint Hard Clear 1 kg resin bottles because they were inadvertently packaged with the wrong Instructions for Use (IFU). These bottles, used for making dental appliances like mouthguards and retainers, were placed inside a zip-lock bag containing instructions for 'KeySplint Soft' instead of the correct 'Hard Clear' instructions. Using the wrong instructions could lead to improper processing of the dental device, though no injuries have been reported. This product was distributed nationwide in the United States and in China.
Following the incorrect instructions meant for a different resin type may result in the dental appliance being manufactured or cured incorrectly, potentially affecting its fit, durability, or safety. Improperly cured resin may not meet the intended material specifications for dental use.
Manufacturer contact for correct instructions
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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