United StatesParagon 28 is recalling two custom-made foot implants: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A (Model 6123S R) and 6123 Navicular Cage Nominal Right Rev A (Model 6123N R), both identified by Lot Number AOCIA6123. The devices were recalled because of elevated oxygen levels above the allowable limit, which may contribute to reduced material ductility; the units were distributed in the United States, including the state of Montana.
What's being recalled
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Recalling firm: Paragon 28, Inc., Englewood, CO, United States.
How to identify it
Lot Number AOCIA6123
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution i the state of MT.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada