Paragon Phantom TTC Nail Recall: Medical Devices Not Sterilized
Paragon 28 recalls Phantom TTC Nails distributed before sterilization. These medical devices pose a risk of infection due to improper sterilization. Affected units include specific model and reference numbers.
Recall notice
Medical devices distributed, prior to sterilization
Contact the company
What happened, in plain English
Paragon 28 is recalling Phantom TTC Nails that were distributed without proper sterilization. This could lead to infection risks for users. The recall affects specific model numbers and reference codes. Read more at govinfonow.com/recall/56501-paragon-phantom-ttc-nail-recall-medical-devices-not-sterilized.
Source Summary by GovInfoNow · govinfonow.com/recall/56501-paragon-phantom-ttc-nail-recall-medical-devices-not-sterilized · Updated August 17, 2026 · FDA enforcement record: FDA #Z-1256-2024
Cite this page
“Paragon Phantom TTC Nail Recall: Medical Devices Not Sterilized.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/56501-paragon-phantom-ttc-nail-recall-medical-devices-not-sterilized. Based on FDA recall #Z-1256-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1256-2024%22&limit=1).
Why it’s dangerous
The hazard occurs because medical devices were distributed without proper sterilization. This can lead to infection risks if the devices are used without being sterilized first. The issue is specific to devices that were not processed correctly.
Who’s affected
Users of Phantom TTC Nails distributed before sterilization are affected. Medical professionals and patients using these devices are at risk of infection.
How to tell if you have this one
Check for the model 'Phantom TTC Nail, 11.5 X 250mm, RIGHT' and reference number 'P31-615-250R' on the device. The product code PA23006856 is also associated with this recall.
- Brand
Paragon 28- Category
Medical device
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US:CA OUS: None
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1254-2024 | Phantom TTC Nail, 10.0 X 200mm, Right; PA23005925 | — |
| Z-1255-2024 | Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L; PA23005922 | 1 |
| Z-1256-2024 | Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R; PA23006856 | 1 |
What to do — step by step
Check Device Details
Look for the model number 'Phantom TTC Nail, 11.5 X 250mm, RIGHT' and reference number 'P31-615-250R' on the device.
Where it went and when
Where it was distributed
Distributed in California.
FDA distribution: “US:CA OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California.
Recall timeline
FDA published this recall 3 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1256-2024 (December 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1256-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.