Class II

Medical Device Recall: KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011

Keystone Industries · November 20, 2023

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).

Distribution

Worldwide distribution - US Nationwide and the country of China.

States Affected

NATIONWIDE

Quantity Affected

336 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0630-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Keystone Industries Medical Device Recall: KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011 | SafeCheck