KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightgua
Summary
The FDA issued a Class II for KeySplint Hard Clear - Indicated for the fabrication of orthodontic and dental by Keystone Industries. Reason: Keyprint Keysplint Hard Clear 1 kg resin bottles were inadvertently packaged with the wrong Instructions for Use. Keysplint Hard Clear were placed ins.
Details
Source
Device Recall
External ID
Z-0630-2024
Action Date
2024-01-10
Status
Ongoing
Category
device
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
Lot/Code Info: UDI: UDI +H66842200111/$$3251116NB3628L Lot No. NB3628
Quantity Affected: 336 units
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-20
Company
Gibbstown, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 84 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Keystone Industries) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Keystone Industries have FDA actions?
Keystone Industries has 25 FDA actions in our database, including 23 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0630-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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