FDAFDA · Food and drugs·Recall number Z-0630-2024
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Published January 10, 2024 · Recall initiated: November 20, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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).
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Keystone Industries
- Distributor
- Worldwide distribution - US Nationwide and the country of China.
- Lot
- UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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