Class II U.S. Food and Drug Administration

Paragon 28, Inc. Phantom recall: Fibula nail system intended for use in fixation of fibular fractures

Recall published 11 months ago

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.

The hazard: Potency, impurity or stability failure

This is a specification failure: testing showed the product does not match what the label promises.

What the notice says: 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.

Why it matters: The product failed a specification test: it may contain more or less active ingredient than the label states, carry an impurity, or degrade before its expiry date. A sub-potent dose can leave a condition untreated; a super-potent one can cause an overdose.

Symptoms and when to call a doctor

The risk depends entirely on the drug. For a medicine where dose matters closely — a blood thinner, an anti-epileptic, a thyroid or heart medicine, insulin — talk to your prescriber before changing anything. Seek urgent care if you have symptoms that suggest too much drug, or if the condition the medicine controls starts breaking through.

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-0871-2026
Published
December 10, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Paragon 28, Inc.
Product type
Medical devices
Units affected
20
Distribution
Nationwide
Made in
United States
Lot / code info
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

Products covered by this recall

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

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

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

  • 501182207125. Expiration

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • March 13th
  • 2030 — 20

Model or item number

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

  • P36-128-130R-S — UDI-DI

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 Potency

Paragon 28, Inc. — This is a specification failure: testing showed the product does not match what the label promises.

  1. Check the lot number on your pack against the codes listed above before you do anything else.
  2. Keep the carton and the leaflet — the lot number is usually printed only on the outer pack.
  3. Report any change in how the medicine is working to FDA MedWatch, which is where most of these signals originate.
  4. Do not stop a prescription on your own. For most conditions an uncertain dose is safer than no dose while you get advice.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

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?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 501182207125. Expiration; best-by date March 13th or 2030 — 20; model number P36-128-130R-S — UDI-DI. 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?

Check the lot number on your pack against the codes listed above before you do anything else.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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