Device recall

Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant

FDA recall source

Recall number

Z-2972-2026

Event id

99504

Status

Ongoing

FDA classification

Class III

Recalling firm

Paragon 28, Inc.

Report date

Aug 26, 2026

Initiated

Jul 10, 2026

Center classification date

Aug 14, 2026

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.

Quantity

1 unit

Code info

Lot Number AOCIA6123

Distribution

US Nationwide distribution i the state of MT.

Voluntary or mandated

Voluntary: Firm initiated

Location

Englewood, CO, United States