Lower riskMedical device recall · FDA · Published June 17, 2026
Paragon 28 Recall: P28 Phantom Hindfoot Nail System Packaging Breach Risk
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 Recall: P28 Phantom Hindfoot Nail System Packaging Breach Risk.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/127769-paragon-28-recall-p28-phantom-hindfoot-nail-system-packaging-breach. Based on FDA recall #Z-2758-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2758-2026%22&limit=1).
The FDA announced on June 17, 2026, that Paragon 28, Inc. is recalling its P28 PHANTON INTRAMEDULLARY NAIL SYSTEM due to breaches in the sterile barrier of the pouch packaging. The recall affects 514 units distributed nationwide and internationally.
How to tell if you have it
Brand: Paragon 28
Product: P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm
Item number: P31-955-1800-S
UPC: 00889795061577
Lot Numbers: 501167202225, 501167302225, 501209514725, 501259627925, 501275832225
The hazard
According to the FDA, two complaints were received involving breaches in the sterile barrier of the pouch packaging for the recalled devices.
Context
GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since December 19, 2017. Recent brand recalls include a July 10, 2026 recall for elevated oxygen risk and an October 13, 2025 recall for thread depth issues. Other recent recalls of similar products include a January 5, 2026 Medline Nail Kit Recall and June 12, 2026 Medline Eye Kits and Convenience Kits Recalls.
How to tell if you have this one
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.
Brand
Paragon 28
Product
P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify your product by checking the model size (0.30 mm), length (800 mm), and lot number from the packaging.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US nationwide, Australia, Canada, The Netherlands, and New Zealand” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 42 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2758-2026 (June 17, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2758-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 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.