Recall Z-0871-2026— Paragon 28, Inc.
Class II · Ongoing
Class II FDA medical device recall by Paragon 28, Inc., initiated 2025-10-13. It names one FDA 510(k) clearance: K234128. 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..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-10-13
- Firm location
- Englewood, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.