Medical Device Recall: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Paragon 28, Inc. · October 13, 2025
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
States Affected
NATIONWIDE
Quantity Affected
20
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0871-2026
Status: ongoing
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