Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0871-2026 — Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

U.S. FDA — Device Enforcement · United States · 2025-10-13 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0871-2026
Date of alert
2025-10-13
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Paragon 28, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00889795133670
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.