Class III

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

Paragon 28, Inc. · July 10, 2026

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.

States Affected

NATIONWIDE

Quantity Affected

1

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2971-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Paragon 28, Inc. Medical Device Recall: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant | SafeCheck