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Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Recalled December 10, 2025 · FDA recall Z-0871-2026 · Paragon 28
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. · FDA Class II
Units
20
Sold at
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Description
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
Manufacturer(s)
Paragon 28, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →