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Recall Observatory FDA recall evidence

Device product

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

Z-0871-2026

October 13, 2025

Class II

Product summary

Firm
Paragon 28, Inc.
Event
Event 97891
Status
Ongoing
Classification
Class II
Quantity
20
Official record key
device-enforcement:Z-0871-2026

Official wording

Reason: 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.

Code information: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

Distribution pattern: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification