FDAHealthOctober 13, 2025
Paragon 28, Inc. — Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 13, 2025
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
What's affected?
- Product
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Brand
- Paragon 28, Inc.
- Lot code
- 501182207125
Additional details
UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 20.
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