Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A — Class III medical device recall Z-2972-2026
Ongoing recall by Paragon 28, Inc., reported 2026-08-26, distributed nationwide. Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels m
| Recall number | Z-2972-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2026-07-10 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
| Lot numbers | AOCIA6123 |
| Model numbers | 6123NR |
Product
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2972-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.