FDA-Device2025-12-10Class II
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Paragon 28, Inc.
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.
Sold states
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Affected count
20
Manufactured in
14445 Grasslands Dr, Englewood, CO, United States
Products
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0871-2026Don't want to check this manually?
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