🔍 RecallPedia

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Class I - Dangerous
🏥 Medical Devices Recalled: October 13, 2025 Paragon 28 Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Paragon 28, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Product Codes/Lot Numbers:

UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0871-2026

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