FDA-Device2025-12-10Class IIPROCESSING DEFECT
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
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.
Intended for
Adults
Illnesses reported
None reported
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-0871-2026More Paragon 28 recalls
- FDA-Device2026-07-29Paragon 28 Phantom Hindfoot Guide Rod recalled for sterile packaging breach
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.