FDA-Device2026-08-26Class IIIPROCESSING DEFECT
Paragon 28 Navicular Cage Small Right foot implant recalled for elevated oxygen level
What this means
Paragon 28 recalled one unit of its Model 6123S R Navicular Cage Small Right foot implant because the device contained elevated oxygen levels above the allowable limit. High oxygen content can reduce the material's ductility, potentially affecting device durability.
- If you received this implant (Lot AOCIA6123), contact your surgeon or healthcare provider immediately.
- Do not have surgery with this device if it has not yet been implanted.
- Your surgeon can confirm whether you are affected and discuss next steps.
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
Manufactured in
14445 Grasslands Dr, Englewood, CO, United States
Products
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2026More Paragon 28 recalls
- FDA-Device2026-07-29Paragon 28 Phantom Hindfoot Guide Rod recalled for sterile packaging breach
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