FDA-Device2026-08-26Class IIIPROCESSING DEFECT
Paragon 28 Model 6123N R navicular foot implant recalled for elevated oxygen contamination
What this means
Paragon 28 recalled one custom-made navicular foot implant (Model 6123N R, Lot AOCIA6123) because it contained elevated oxygen levels beyond acceptable limits. Elevated oxygen can reduce the material's ductility, potentially affecting device performance.
- If you received this implant, contact your surgeon or Paragon 28 immediately to discuss your options.
- Do not use the device if it has not yet been implanted.
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution i the state of MT.
Affected count
1 unit
Manufactured in
14445 Grasslands Dr, Englewood, CO, United States
Products
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2972-2026More Paragon 28 recalls
- FDA-Device2026-08-26Paragon 28 Navicular Cage Small Right foot implant recalled for elevated oxygen level
- FDA-Device2026-07-29Paragon 28 Phantom Hindfoot Guide Rod recalled for sterile packaging breach
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