Reported Dec 10, 2025 · Ongoing
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Paragon 28, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Paragon 28, Inc. · 14445 Grasslands Dr · Englewood, CO · 80112-7062
Is this the product you have?
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail
- REFP36-128-130R-S
- Lot codes and dates
- UDI-DI00889795133670
- Lot501182207125
- Expiration
March 13th2030
- Amount recalled
- 20
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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