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 | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. |
| Product | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle. |
| Quantity | 514 units |
| Distribution | US nationwide, Australia, Canada, The Netherlands, and New Zealand |
| Initiated | 2026-06-17 |
| Classified | 2026-07-17 |
| Recall number | Z-2758-2026 |
| 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-2758-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99276/
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