Summary
The FDA issued a Class II for Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R by Paragon 28, Inc.. Reason: Medical devices distributed, prior to sterilization.
Details
Source
Device Recall
External ID
Z-1256-2024
Action Date
2024-03-13
Status
Ongoing
Category
device
Product Description
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Lot/Code Info: PA23006856
Quantity Affected: 1
Reason for Recall
Medical devices distributed, prior to sterilization
Distribution
US:CA OUS: None
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Englewood, CO
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 225 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 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 (Paragon 28, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1256-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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