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Paragon 28 Phantom Intramedullary Nail System Guide Rod
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MEDICAL DEVICE RECALLMODERATE

Paragon 28 Phantom Intramedullary Nail System Guide Rod

Paragon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.

What to do

Do not use the affected guide rod if the sterile packaging is compromised. Contact Paragon 28 for further instructions regarding the return and replacement of the product.

Recalled
Listed
Updated
Recall No.
Z-2758-2026
Agency
FDA
Firm
Paragon 28, Inc.
Recall ID
99276
Status
ONGOING

Recall at a glance

Quantity recalled
514 units

Why it was recalled

Paragon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod due to potential breaches in the sterile barrier of the product packaging. The affected item number is P31-955-1800-S.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number P31-955-1800-S; provides stabilization of the hindfoot and ankle.

UDI-DI
00889795061577, 501167202225, 501167202225, 00889795061577, 501167302225, 501167302225, 00889795061577, 501209514725, 501209514725, 00889795061577, 501259627925, 501259627925, 00889795061577, 501275832225, 501275832225

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-07-20 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification