Recall Z-2971-2026— Paragon 28, Inc.
Class III · Ongoing
Class III FDA medical device recall by Paragon 28, Inc., initiated 2026-07-10. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2026-07-10
- Firm location
- Englewood, CO, United States
Product description
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Reason for recall
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Data sourced from openFDA. This site is unofficial and independent of the FDA.