LowFDAOngoing
Unlikely to cause harm, but it breaks the rules.
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Check the device or its packaging for
Lot Number AOCIA6123
- 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.
- Distributed
- US Nationwide distribution i the state of MT.
- Company
- Paragon 28, Inc.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-2972-2026 · retrieved 14 August 2026
Read the official notice