Paragon 28, Inc. recalls Phantom Fibula Nail

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.

On 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting Orders@paragon28.com Complaints can be directed to complaints@paragon28.com

• FDA enforcement recordOfficial FDA database entry for Z-0871-2026
• FDA 510(k) clearance · K234128The device's official FDA premarket clearance record
• FDA device classification · HSBOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3020The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Paragon 28, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.