Phantom Nail System — Class II medical device recall Z-2488-2021
Terminated recall by Paragon 28, Inc., reported 2021-09-29, distributed nationwide. A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause
| Recall number | Z-2488-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Paragon 28, Inc., Englewood, CO, United States |
| Recall initiated | 2021-07-30 |
| Classified | 2021-09-17 |
| Reported by FDA | 2021-09-29 |
| Terminated | 2021-12-15 |
| Distributed | Nationwide (US) |
| Quantity | 14 drill |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00889795056849 |
| Lot numbers | HN120550 |
| Model numbers | P99-110-4630 |
Product
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Reason for recall
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.
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-2488-2021. 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.