Paragon 28, Inc. recalls Phantom Fibula Nail
- Recalling company
- Paragon 28, Inc.
- Product
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Reason
- 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 II – may cause temporary or medically reversible health consequences
- Recall date
- Oct 13, 2025
- Reported
- Dec 10, 2025
- Distribution
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
- Status
- Ongoing
- Quantity
- 20
- Lot / codes
- UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030
- Company location
- Englewood, CO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0871-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0871-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.