FDA recall, , Low risk
Paragon 28 Navicular Cage Foot Implants
The foot implant has elevated oxygen levels that may reduce material ductility.
Summary by Recall Canary from the FDA notice
What happened
Paragon 28, Inc., of Englewood, Colorado, recalled two custom made foot implants because an elevated oxygen level in excess of the allowable limit may contribute to reduced material ductility. The recalled products are the Custom Made Device Implant 6123 Navicular Cage Small Right Rev and the Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev.
The company began the recall on July 10, 2026, and the FDA added it to the Enforcement Report on August 14, 2026. Distribution was in the state of MT.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its lot code is listed.
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
- Lot code
- AOCIA6123
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
- Lot code
- AOCIA6123
Recall details
- Company began the recall
- Sold in
US Nationwide distribution i the state of MT.
- Company
- Paragon 28, Inc.Englewood, Colorado
- Hazard
- Device defect
- Risk
Low risk
Using it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99504
- Recall numbers
- Z-2971-2026 to Z-2972-2026
All recalls from Paragon 28, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
