Z-0630-2024 Class II Ongoing
FDA device recall Z-0630-2024 was initiated by Keystone Industries on November 20, 2023 and is designated Class II. 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 Instr… The recall status is ongoing. Affected quantity: 336 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 20, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 336 units
Product Description
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
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 Pattern
Worldwide distribution - US Nationwide and the country of China.
Code Information
UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628