Use cautionMedical device recall · FDA · Published October 13, 2025
Paragon Phantom Fibula Nail Recall: Thread Depth Issue May Cause Surgery Abortion
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.
Take action
Contact the company
📍Recalling firmParagon 28, Inc.14445 Grasslands Dr · Englewood, CO 80112-7062
“Paragon Phantom Fibula Nail Recall: Thread Depth Issue May Cause Surgery Abortion.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51060-paragon-phantom-fibula-nail-recall-thread-depth-issue-may-cause. Based on FDA recall #Z-0871-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0871-2026%22&limit=1).
Paragon 28, Inc. recalled one Phantom Fibula Nail on Oct. 13, 2025, because out-of-specification thread depths may prevent proper mating with mounting bolts. The Food and Drug Administration announced the Class II recall.
How to tell if you have it
Brand: Paragon 28
Product: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti
REF: P36-128-130R-S
UDI-DI: 00889795133670
Lot: 501182207125
Expiration: March 13th, 2030
Units affected: 20
The hazard
The fibula nail system intended for fixation of fibular fractures and osteotomies has out-of-specification thread depths. If the implant cannot properly mate with instrumentation, surgery potentially will need to be aborted.
Context
GovInfoNow's records show Paragon 28, Inc. has had nine other recalls since Dec. 19, 2017. Recent brand recalls include a July 10, 2026 recall for elevated oxygen risk in Custom Foot Implants and a June 17, 2026 recall regarding packaging breach risks in the P28 Phantom Hindfoot Nail System. Other recent recalls of similar products include the Smith & Nephew TRIGEN Humeral Nail Recall (March 16, 2026) and Zimmer Affixus Antegrade Femoral Nails Recall (Dec. 2, 2025).
How to tell if you have this one
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.
Brand
Paragon 28
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the model number P36-128-130R-S and lot number 501182207125 on the product.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 13 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Illinois, Louisiana, Maryland, Nevada, New Jersey, New Mexico, New York, Ohio, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 58 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-0871-2026 (October 13, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0871-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.