Keystone Industries recalls KeySplint Hard Clear resin bottles due to incorrect instructions for use. This could lead to improper fabrication of dental appliances if users follow the wrong instructions.
Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed inside a zip lock bag along with KeySplint Soft Instructions for Use (IFU).
Keystone Industries is recalling KeySplint Hard Clear resin bottles because they were shipped with the wrong instructions for use. This could lead to improper fabrication of dental appliances like mouthguards if users follow the incorrect instructions.
The resin bottles were packaged with the wrong Instructions for Use (IFU) that include the softer KeySplint Soft instructions instead of the hard resin instructions. This could lead to users creating dental appliances that don't work properly if they follow the incorrect instructions.
People who own or use KeySplint Hard Clear resin bottles for dental appliances like mouthguards are affected. Those who follow the wrong instructions could create improper dental appliances.
Check for KeySplint Hard Clear resin bottles with item number 4220011 and UDI UDI +H66842200111/$$3251116NB3628L. The bottles were sold with the wrong instructions for use.
Verify the Instructions for Use (IFU) included with the product. If the IFU contains KeySplint Soft instructions instead of Hard Clear instructions, the product is recalled.
Keystone Industries recalls KeySplint Hard Clear resin bottles because they were inadvertently packaged with the wrong Instructions for Use (IFU). The IFU includes KeySplint Soft instructions instead of the correct Hard Clear instructions.
Check the Instructions for Use (IFU) included with the product. If the IFU contains KeySplint Soft instructions instead of Hard Clear instructions, the product is recalled and you should verify the correct instructions.
The recall record does not specify a remedy. You should check the Instructions for Use to ensure you are using the correct instructions for the product.
We’ve drafted a message you can send Keystone Industries to request your refund or repair — edit it as you like.
Subject: Recall Z-0630-2024 — Keystone Industries Keystone Industries Hello, I own a Keystone Industries that is covered by recall Z-0630-2024 from Keystone Industries. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
