Paragon 28 Navicular Cage Foot Implant
Paragon 28 recalls Navicular Cage foot implant (Model 6123S R) due to elevated oxygen levels.
Contact Paragon 28, Inc. for instructions on returning the affected implant and to discuss replacement options.
Why it was recalled
Paragon 28, Inc. is recalling the Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R, a foot implant, because an elevated oxygen level in excess of the allowable limit may reduce material ductility.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Custom Made Device Implant 6123 Navicular CageLot code: AOCIA6123
| Product | Recall # |
|---|---|
| Small Right Rev A, Model/Catalog Number 6123S R; foot implant | Z-2971-2026 |
| Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant | Z-2972-2026 |
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Paragon 28, Inc.
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification