FDA Device recall Z-1256-2024
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
- FDA Device
- Class II
- ongoing
- Published 2024-03-13
On 2024-03-13 the FDA classified a Class II recall of Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R by Paragon 28, citing medical devices distributed, prior to sterilization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1256-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-21 |
| Published | 2024-03-13 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Paragon 28 |
| Distribution | CA |
Product
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Reason
Medical devices distributed, prior to sterilization
Identifiers
| code_info | PA23006856 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Device · Class III · 2026-08-26 · 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
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1256-2024%22
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