Paragon 28 recalls Phantom Fibula Nails with improper thread depth that could require surgery abortion. Affected items have specific model and lot numbers. Contact for remedy.
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.
Paragon 28 is recalling Phantom Fibula Nails that have thread depths outside specifications. This could cause the surgery to need to be aborted if the nail doesn't properly attach to the mounting bolt.
The fibula nail has thread depths that don't match the mounting bolt. If the nail can't attach properly, the surgery might need to be stopped and restarted, which could delay healing or cause complications.
Surgical patients who received the recalled Phantom Fibula Nails during procedures. Surgeons and medical staff using the product are most at risk.
Check for the model: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S. Lot number 501182207125 and expiration date March 13, 2030.
Look for the model number P36-128-130R-S and lot number 501182207125 on the product.
The fibula nail has thread depths outside specifications, which could prevent proper attachment to the mounting bolt and require surgery to be aborted.
Check the product details for the model number P36-128-130R-S and lot number 501182207125. The recall record does not specify a remedy.
The recall states the surgery might need to be aborted, but the record does not mention injury risks.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-0871-2026 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-0871-2026 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.
