FDA Device recall Z-2972-2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R
- FDA Device
- Class III
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class III recall of Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R by Paragon 28, citing device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2972-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-07-10 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Paragon 28 |
| Distribution | US |
Product
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N 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.
Identifiers
| code_info | Lot Number AOCIA6123 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2972-2026%22
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