CLASS II ONGOING Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
KeySplint Hard Clear - Indicated recalled by Keystone Industries
Keystone Industries is recalling KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances, distributed nationwide in the US. The recall was initiated on 20 Nov 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0630-2024
- FDA event ID
- 93522
- Recalling firm
- Keystone Industries, Gibbstown, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Nov 2023
- FDA classified
- 3 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Packaging Defects
- Device type
- Dental Devices
Timeline
| 20 Nov 2023 | Recall initiated by company | |
| 3 Jan 2024 | Classified by FDA | +44 days |
| 10 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Where it was distributed
Worldwide distribution - US Nationwide and the country of China.
Questions about this recall
Is KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances recalled?
Yes. Keystone Industries recalled KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances on 20 Nov 2023. The recall is Class II and its status is Ongoing. Recall number Z-0630-2024.
Why was it recalled?
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).
Which lots are affected?
UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Where was it sold?
Worldwide distribution - US Nationwide and the country of China.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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