Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Reported: December 10, 2025 Initiated: October 13, 2025 #Z-0871-2026
Product Description
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
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.
Details
- Recalling Firm
- Paragon 28, Inc.
- Units Affected
- 20
- Distribution
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
- Location
- Englewood, CO
Frequently Asked Questions
What product was recalled? ▼
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S. Recalled by Paragon 28, Inc.. Units affected: 20.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 10, 2025. Severity: Moderate. Recall number: Z-0871-2026.
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