FDA Device recall Z-2488-2021
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
- FDA Device
- Class II
- terminated
- Published 2021-09-29
On 2021-09-29 the FDA classified a Class II recall of Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 by Paragon 28, citing A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2488-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-07-30 |
| Published | 2021-09-29 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Paragon 28 |
| Distribution | US |
Product
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Reason
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Identifiers
| code_info | Model Number: P99-110-4630 UDI Code: (01)00889795056849(10)HN120550 Lot Number: HN120550 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
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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-2488-2021%22
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