Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Summary
The FDA issued a Class III for Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog by Paragon 28, Inc.. Reason: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductil.
Details
Source
Device Recall
External ID
Z-2971-2026
Action Date
2026-08-26
Status
Ongoing
Category
device
Product Description
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Lot/Code Info: Lot Number AOCIA6123
Quantity Affected: 1
Reason for Recall
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Distribution
US Nationwide distribution i the state of MT.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-10
Company
Englewood, CO
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 149 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Paragon 28, Inc. has 38 FDA actions in our database, including 10 recalls and 28 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 10 recalls and 28 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2971-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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