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

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).

Details from the source

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. Quantity: 336 units Lot/code info: UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.