Class II — Paragon 28, Inc.
| Recalling firm | Paragon 28 |
|---|---|
| Registered facility | PARAGON 28 (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| Product | Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630 |
| Quantity | 14 drill bits |
| Distribution | U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A |
| Initiated | 2021-07-30 |
| Classified | 2021-09-17 |
| Terminated | 2021-12-15 |
| Recall number | Z-2488-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Paragon 28, Inc. (Z-2488-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/88553/
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