⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Paragon 28, Inc.: Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

Medical DevicesSource: FDA (device) · Date: 2026-08-26

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Paragon 28, Inc.
Product
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Reason / hazard
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Classification
Class III
Status
Ongoing
Distribution / sold at
US Nationwide distribution i the state of MT.
Recall initiated
2026-07-10
Code info
Lot Number AOCIA6123
Product quantity
1 unit
Voluntary mandated
Voluntary: Firm initiated
City
Englewood
State
CO
Country
United States
Event id
99504
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