Z-0630-2024Class II

KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as...

Name: Z-0630-2024 KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as...
Creator: Keystone Industries
Published: 2023-11-20
License: https://open.fda.gov/license/

Keystone Industries / initiated 2023-11-20 / Open, Classified / root cause: labeling and UDI

FDA source

Keystone Industries began a recall of KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and... on 2023-11-20. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0630-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-20
Posted: 2024-01-03
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
Product code: MQC Mouthguard, Prescription
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).
Root cause tag: labeling and UDI
FDA 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 [email protected] 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 in commerce: 336 units
Distribution: Worldwide distribution - US Nationwide and the country of China.
Product codes and lots: UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0630-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0630-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-03

Product code MQC

K203000UnclassifiedKeyPrint KeySplint HardMycone Dental Supply Co. Inc. (Dba Keystone Industries) / cleared 2021-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)