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Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Recalled August 26, 2026 · FDA recall Z-2971-2026 · Paragon 28
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. · FDA Class III
Units
1
Sold at
US Nationwide distribution i the state of MT.
Description
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Product
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Manufacturer(s)
Paragon 28, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →