FDAFDA · Food and drugs·Recall number Z-0871-2026
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Published December 10, 2025 · Recall initiated: October 13, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Paragon 28, Inc.
- Distributor
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
- Lot
- UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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