Paragon 28 recalls P28 Phantom Hindfoot Nail System due to potential sterile packaging breaches. Affected units have specific model and lot numbers. Consumers should check their product details and contact the company for guidance.
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
Paragon 28 is recalling a specific type of ankle stabilization nail system because two complaints reported breaches in the sterile packaging. This could lead to infection if the product is used without proper sterilization.
The sterile packaging for the nail system could have been compromised, potentially allowing contamination. If the packaging is breached, the product might not be sterile when used, increasing the risk of infection during surgery.
Orthopedic surgeons and medical professionals who use the P28 Phantom Hindfoot Nail System for ankle stabilization procedures are most at risk. Patients using this system are not directly affected by the packaging issue.
Check for the product name 'P28 PHANTOM INTRAMEDULLARY NAIL SYSTEM' with model size 0.30 mm and length 800 mm. Look for lot numbers 501167202225, 501167302225, 501209514725, or 501259627925.
Identify your product by checking the model size (0.30 mm), length (800 mm), and lot number from the packaging.
No, the recall is due to potential packaging breaches, not a defect in the product itself. Proper use with intact packaging should be safe.
Check the product model size (0.30 mm), length (800 mm), and lot number from the packaging. Affected units have specific lot numbers listed in the recall notice.
The recall does not require immediate action. Contact Paragon 28 directly to confirm your product's status and get guidance.
We’ve drafted a message you can send Paragon 28 to request your refund or repair — edit it as you like.
Subject: Recall Z-2758-2026 — Paragon 28 Paragon 28 Hello, I own a Paragon 28 that is covered by recall Z-2758-2026 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.
