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 | Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant) cannot properly mate with instrumentation, the surgery potentially will need to be aborted. |
| Product | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. |
| Initiated | 2025-10-13 |
| Classified | 2025-12-02 |
| Recall number | Z-0871-2026 |
| 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-0871-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97891/
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