Paragon 28, Inc.: Medical Device Recall in 2025 - (Recall #: Z-0871-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 13, 2025

Date Posted: December 10, 2025

Recall Number: Z-0871-2026

Event ID: 97891

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 20

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.

Voluntary or Mandated:

Voluntary: Firm initiated