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Class IIIOngoing

Paragon 28, Inc. recalls 2 products

Recall date · record updated Aug 26, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
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 ductility.
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution i the state of MT.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99504…

Products (2)

  1. Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

    Codes/lots: Lot Number AOCIA6123Quantity: 1Recall no. Z-2971-2026Class III

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

    Codes/lots: Lot Number AOCIA6123Quantity: 1 unitRecall no. Z-2972-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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