Paragon 28, Inc.: Device Recall
Recall #Z-0871-2026 · 10/13/2025
Class II: Risk
Recall Details
- Recall Number
- Z-0871-2026
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Paragon 28, Inc.
- Status
- Ongoing
- Date Initiated
- 10/13/2025
- Location
- Englewood, CO, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
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.
Product Description
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Distribution Pattern
US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.