The Recall Desk
LowFDA (Devices)·Z-2972-2026·Announced 2026-08-26

Paragon 28 Recalls Custom Foot Implant Due to Material Defect

Paragon 28, Inc. is recalling a custom-made foot implant due to elevated oxygen levels that may reduce material ductility.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The agency classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.

Plain-English summary

Paragon 28, Inc. is recalling one unit of the Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R. This is a custom-made foot implant with Lot Number AOCIA6123.

The device was recalled because it had an elevated oxygen level in excess of the allowable limit. According to the recall notice, elevated oxygen levels may contribute to reduced material ductility.

The affected unit was distributed in the state of Montana. No specific patient names or additional distribution details are provided in the source text.

The recalled product

Product
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Manufacturer
Paragon 28, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
1

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number AOCIA6123

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · Paragon 28, Inc.

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Same hazard · material defect

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