Fresh Recalls

Paragon 28 recalls

3 recent recalls on record for Paragon 28 in connected official government data as of October 22, 2026 at 6:00 PM UTC.

Models with recalls

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A (1)Custom Made Device Implant 6123 Navicular Cage Small Right Rev A (1)P28 PHANTON INTRAMEDULLARY NAIL SYSTEM (1)

All Paragon 28 recalls

FDA Class III · Medical device · August 26, 2026

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A recall — Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Official ID Z-2972-2026 · Official record ↗

FDA Class III · Medical device · August 26, 2026

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A recall — Paragon 28, Inc.

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Official ID Z-2971-2026 · Official record ↗

FDA Class II · Medical device · July 29, 2026

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM recall — Paragon 28, Inc.

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Official ID Z-2758-2026 · Official record ↗

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Compiled from official public-domain government data. Last checked October 22, 2026 at 6:00 PM UTC.