Recall Z-0871-2026 ยท HSB Rod, Fixation, Intramedullary And Accessories
Paragon 28, Inc.
Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
| Date | Dec 2, 2025 (initiated Oct 13, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | On 10/13/2025, recall notices were emailed to distributors who were asked to do the following: 1) Return affected devices to the firm using return label. 2) Ensure that in instances where you have distributed this affected product, that you forward this Recall Notification to your customers. 3) Replacements are available by contacting Orders@paragon28.com Complaints can be directed to complaints@paragon28.com |
| Quantity | 20 |
| Distribution | US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K234128 | Phantom Fibula Nail System Paragon 28, Inc., Aug 22, 2024 |