medical Class II Updated 2024-01-10

Keystone Industries recalls KeySplint Hard Clear - Indicated for the fabrication of orth

Recalled Product

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


Hazard / Issue

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).

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
View official government recall

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