Recall Z-0630-2024 ยท MQC Mouthguard, Prescription
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
| Date | Jan 3, 2024 (initiated Nov 20, 2023) |
| Status | Open, Classified |
| 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 t |
| Quantity | 336 units |
| Distribution | Worldwide distribution - US Nationwide and the country of China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203000 | KeyPrint KeySplint Hard Mycone Dental Supply Co. Inc. (Dba Keystone Industries), Apr 9, 2021 |