Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Paragon 28, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paragon 28, Inc. · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
- Lot codes and dates
- Lot Number AOCIA6123
- Amount recalled
- 1 unit
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MT
Why it was recalled
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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