FDA Device recall Z-2971-2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S 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 Small Right Rev A, Model/Catalog Number 6123S 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-2971-2026 |
| 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 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.
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.
Other recalls by Paragon 28
- Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R
FDA Device · Class III · 2026-08-26 · Paragon 28 - P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-…
FDA Device · Class II · 2026-07-29 · Paragon 28 - Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
FDA Device · Class II · 2025-12-10 · Paragon 28 - Phantom TTC Nail, 10.0 X 200mm, Right
FDA Device · Class II · 2024-03-13 · Paragon 28 - Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
FDA Device · Class II · 2024-03-13 · Paragon 28
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2971-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.