Class II U.S. Food and Drug Administration

Paragon 28, Inc. P28 Phanton Intramedullary Nail System, Phantom Hindfoot TTC/TC Ball recall: Paragon 28 received two (2) complaints were received involving breaches

Recall published 3 months ago

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2758-2026
Published
July 29, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Paragon 28, Inc.
Product type
Medical devices
Units affected
514 units
Distribution
Nationwide
Made in
United States
Lot / code info
UDI (01)00889795061577(17)300122(10)501167202225, Lot Number 501167202225; UDI (01)00889795061577(17)300122(10)501167302225, Lot Number 501167302225; UDI (01)00889795061577(17)300527(10)501209514725, Lot Number 501209514725; UDI (01)00889795061577(17)301006(10)501259627925, Lot Number 501259627925; UDI (01)00889795061577(17)301118(10)501275832225, Lot Number 501275832225.
UPC codes
00889795061577, 501167202225, 501167302225, 501209514725, 501259627925, 501275832225

Products covered by this recall

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.

Check your product

The notice names 12 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00889795061577
  • 501167202225
  • 501167302225
  • 501209514725
  • 501259627925
  • 501275832225

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 501167202225
  • 501167302225
  • 501209514725
  • 501259627925
  • 501275832225. — 514 units

Model or item number

On the rating label, the box or the instruction sheet.

  • P31-955-1800-S

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Paragon 28, Inc. — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Do not use a vial or syringe with visible particles, cloudiness or discolouration, whether or not it is on the recall list.
  3. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  4. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Paragon 28, Inc. — 14445 Grasslands Dr, Englewood, CO, 80112-7062

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Paragon 28, Inc. medical devices recalled?

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging. Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00889795061577, 501167202225, 501167302225; lot code 501167202225, 501167302225, 501209514725; model number P31-955-1800-S. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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