Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Summary
The FDA issued a Class II for Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S by Paragon 28, Inc.. Reason: Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so im.
Details
Source
Device Recall
External ID
Z-0871-2026
Action Date
2025-12-10
Status
Ongoing
Category
device
Product Description
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Lot/Code Info: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
Quantity Affected: 20
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-13
Company
Englewood, CO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 336 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Paragon 28, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Paragon 28, Inc. have FDA actions?
Paragon 28, Inc. has 38 FDA actions in our database, including 8 recalls and 30 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0871-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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