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Paragon 28, Inc.: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Medical DevicesSource: FDA (device) · Date: 2025-12-10

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Paragon 28, Inc.
Product
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Recall initiated
2025-10-13
Code info
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Product quantity
20
Voluntary mandated
Voluntary: Firm initiated
City
Englewood
State
CO
Country
United States
Event id
97891
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