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.
Take action
Contact the company
📍Recalling firmParagon 28, Inc.14445 Grasslands Dr · Englewood, CO 80112-7062
“Paragon 28 Phantom Nail Drill Recall: Thin Wall Risk of Fracture.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62114-paragon-28-phantom-nail-drill-recall-thin-wall-risk-of. Based on FDA recall #Z-2488-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2488-2021%22&limit=1).
Paragon 28, Inc. recalled its Phantom Nail System Drill on July 30, 2021, according to the FDA. The device has a thin wall condition that could cause a fracture through the drill wall to the cannulation beneath.
How to tell if you have it
Brand: Paragon 28
Product: Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Model Number: P99-110-4630
UPC: 00889795056849
Lot Number: HN120550
The hazard
The recall involves 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, according to the FDA.
Context
GovInfoNow's records show Paragon 28, Inc. has 9 other recalls on record since 2017-12-19. Other recent recalls include a Custom Foot Implant recall on 2026-07-10 due to elevated oxygen risk and a P28 Phantom Hindfoot Nail System packaging breach risk recall on 2026-06-17.
How to tell if you have this one
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.
Brand
Paragon 28
Product
Phantom Nail System, Drill, 4.6 x 300mm, Cannulated, 3/16" Sq. Connection p28 P99-110-4630
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for the model number P99-110-4630 on the drill to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “U.S. Nationwide distribution in the states of CA, FL, GA, ID, KS, KY, LA, MI, MO, NC, NY, TX, VA, WA and WV. O.U.S.: N/A” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Idaho, Kansas, Kentucky, Louisiana, Michigan, Missouri, New York, North Carolina, Texas, Virginia, Washington, West Virginia.
Recall timeline
FDA terminated this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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 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-2488-2021 (July 30, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2488-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 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.