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Keystone Industries recalls KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua
Recalled January 10, 2024 · FDA recall Z-0630-2024 · Keystone Industries
Hazard
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). · FDA Class II
Units
336 units
Sold at
Worldwide distribution - US Nationwide and the country of China.
Description
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).
Product
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Manufacturer(s)
Keystone Industries
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →