Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall (Paragon 28, Inc.)
Medical deviceClass IIIOngoing
Summary: Paragon 28, Inc. is recalling Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant. Reason: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
What is being recalled
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Why
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide distribution i the state of MT. (states named: Montana)
How to tell if yours is affected
Lot Number AOCIA6123
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2971-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | July 10, 2026 |
| Reported | August 26, 2026 |
| Company | Paragon 28, Inc. |
| Company location | Englewood, CO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 |
More recalls from Paragon 28, Inc. · all medical device recalls · recalls from July 2026