Paragon 28 recalls Phantom Nail System Drills with thin wall condition that may fracture, risking injury. Affected models include P99-110-4630.
A thin wall condition between the inner cannulation and the flutes of the drill which potentially could cause a fracture through the wall of the drill to the cannulation beneath.
Paragon 28 is recalling Phantom Nail System drills that have a thin wall which could fracture, potentially causing injury. This recall affects specific models sold with a particular lot number.
The drill has a thin wall between the inner cannulation and flutes that could fracture, potentially causing injury to the user. This structural weakness may lead to the drill breaking during use.
Users of the Phantom Nail System drill with model P99-110-4630 and lot number HN120550 are most at risk. This recall targets specific manufacturing batches.
Check for the model number P99-110-4630 and lot number HN120550 on the drill. This specific model was sold with the lot number HN120550.
Look for the model number P99-110-4630 on the drill to confirm if it is affected.
The recall states a thin wall condition that could potentially cause a fracture, but the risk level is low. The manufacturer has not specified a need to stop using immediately.
The recall does not provide a specific remedy, so there is no action required beyond checking the model number and lot number.
Check for the model number P99-110-4630 and lot number HN120550 on the drill. This specific model was sold with the lot number HN120550.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-2488-2021 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-2488-2021 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.
