Keystone KeySplint Hard Clear: Wrong Instructions May Cause Misuse
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.
Lower-risk recall
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).
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What happened, in plain English
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. Read more at govinfonow.com/recall/56796-keystone-keysplint-hard-clear-wrong-instructions-may-cause-misuse.
Source Summary by GovInfoNow · govinfonow.com/recall/56796-keystone-keysplint-hard-clear-wrong-instructions-may-cause-misuse · Updated August 10, 2026 · FDA enforcement record: FDA #Z-0630-2024
Cite this page
“Keystone KeySplint Hard Clear: Wrong Instructions May Cause Misuse.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/56796-keystone-keysplint-hard-clear-wrong-instructions-may-cause-misuse. Based on FDA recall #Z-0630-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0630-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Keystone Industries- Category
Medical device
What to do — step by step
Check Instructions
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.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the country of China.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 51 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0630-2024 (November 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0630-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.