Keystone Industries KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011 Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Brand
Keystone Industries
Lot Codes / Batch Numbers
UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Products Sold
UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Keystone Industries is recalling KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mo due to Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed ins. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
Keystone Industries issued Urgent Medical Device Recall/Correction letter to Distributors between 10/20/2023 and 10/23/2023. Letter states reason for recall, health risk and action to take: For immediate access, the correct IFU is available following this link: 4916111-NATLAB-1372-KeySplint_Hard_DOMESTIC_IFU_WEB.pdf (keystoneindustries.com) IMMEDIATE ACTIONS TO BE TAKEN 1. Review product inventory and quarantine all affected product on hand. Open zip lock bag and remove the incorrect IFU. Place an X across the front panel of the IFU using a marker or pen. Take a picture of the IFU with an X then discard the IFUs. Record the information on the attached acknowledgement form. 2. Keystone Industries will send you the correct IFUs for any items remaining in your inventory upon receipt of the acknowledgement form. 3. Review distribution records and identify all customers who were shipped the affected product lot. 4. Send End User Notifications provided to you with this notification to all identified customers that received product. Record evidence of notification on the acknowledgement form. Complete the attached Acknowledgement of Medical Device Recall Form and return within 5 days of receiving this notice. Email the completed form to amcclure@keystoneind.com If you have any questions after reviewing this notice, please email using the address below or call Caleb Barylski at 856-548-5205 between 8:00 am and 5:00 pm EST, Monday through Friday.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026