Official recall notice
FDA DeviceClass IIINotable
FDA Recall: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot
- Recall date
- 2026-08-26
- Brand
- Paragon 28, Inc.
- Category
- Medical Device
- FDA class
- Class III
Why it was recalled
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.
Product 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.
Affected products
Lot Number AOCIA6123