KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011
Reported: January 10, 2024 Initiated: November 20, 2023 #Z-0630-2024
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).
Details
- Recalling Firm
- Keystone Industries
- Units Affected
- 336 units
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
- Location
- Gibbstown, NJ
Frequently Asked Questions
What product was recalled? ▼
KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers Item No.: 4220011. Recalled by Keystone Industries. Units affected: 336 units.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Moderate. Recall number: Z-0630-2024.
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