Quick Facts at a Glance
- Recall Date
- October 13, 2025
- Hazard Level
- HIGH
- Brand
- Paragon 28
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, INFANTS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Paragon 28
- Product type
- Fibula Nail System Implant
- Model numbers
- UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 13, 2025
Reported by FDA DEVICE
December 10, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Paragon 28, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Fibula nails are implanted to fix fibular fractures or perform osteotomies. The Phantom Fibula Nail by Paragon 28 is titanium and designed for use in orthopedic surgery.
Why This Is Dangerous
Out-of-spec thread depths may prevent proper mating with the mounting bolt. If the nail cannot mate with instrumentation, the surgery potentially will be aborted and the procedure may need to be redone.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Clinicians may need to alter surgical plans or abort procedures. No injuries or incidents have been reported to date.
Practical Guidance
How to identify if yours is affected
- Check for the Phantom Fibula Nail, 2.8mm x 130mm Right Titanium model.
- Review packaging for UDI-DI 00889795133670 and Lot 501182207125.
- Verify expiration date March 13th.
Where to find product info
See FDA recall page linked in notice for official instructions. Manufacturer contact is Paragon 28, Inc.
What timeline to expect
No specific replacement timeline provided. Follow manufacturer and healthcare provider instructions.
If the manufacturer is unresponsive
- Document all attempts to contact Paragon 28 or the hospital procurement team.
- If issues persist, contact FDA recall resources for escalation.
How to prevent similar issues
- Verify device compatibility with instrumentation before use.
- Keep up-to-date on recall notices for orthopedic implants.
- Consult surgeons before implanting any device with uncertain compatibility.
Documentation advice
Retain the recall notification letter, document unit numbers and lot numbers, keep correspondence with providers and manufacturers.
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Product Details
Model numbers: UDI-DI 00889795133670. Lot: 501182207125. Expiration: March 13th. Additional model: 2030. Distribution: US nationwide in NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. Manufacturer: Paragon 28, Inc. Recall date: 2025-10-13. Status: ACTIVE. Quantity: 20.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 20 units recalled nationwide
- Phantom Fibula Nail, 2.8mm x 130mm Right, Ti
- Expiration: March 13th (year not specified)
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