FDA Medical Device Recalls (openFDA)
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 number
- Z-0630-2024
- Recalling firm
- Keystone Industries
- Product
- KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
- Status
- Open, Classified
- Initiated
- 2023-11-20
- Posted
- 2024-01-03
- Terminated
- not on file
- Reason
- 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).
- Root cause
- Labeling mix-ups
- Action
- 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.
- Quantity
- 336 units
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
- Lot, serial or model codes
- UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
- 510(k) numbers
- ["K203000"]
- PMA numbers
- not on file
- Product code
- MQC
- Firm FEI
- 3010002722
- Firm city
- Gibbstown
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28