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.
Medical devices distributed, prior to sterilization
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.
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.
Users of Phantom TTC Nails distributed before sterilization are affected. Medical professionals and patients using these devices are at risk of infection.
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.
Look for the model number 'Phantom TTC Nail, 11.5 X 250mm, RIGHT' and reference number 'P31-615-250R' on the device.
The recall is because medical devices were distributed without proper sterilization, which could lead to infection risks.
The official notice does not specify a remedy, so check with Paragon 28 for further instructions.
Check for the model 'Phantom TTC Nail, 11.5 X 250mm, RIGHT' and reference number 'P31-615-250R' on the device.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-1256-2024 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-1256-2024 from Paragon 28. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
