Class II — Paragon 28, Inc.
| Recalling firm | Paragon 28 |
|---|---|
| Registered facility | PARAGON 28 (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Medical devices distributed, prior to sterilization |
| Product | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L |
| Quantity | 1 |
| Distribution | US:CA OUS: None |
| Initiated | 2023-12-21 |
| Classified | 2024-03-05 |
| Recall number | Z-1255-2024 |
| 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-1255-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93900/
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