Fibula Nail Recall: Paragon 28 Phantom 2.8x130 Right Ti
Announced 2026-08-26 · FDA
Paragon 28, Inc. recalls 20 Phantom Fibula Nails (2.8 mm x 130 mm, Right, Ti) with lot 501182207125 and UDI-DI 00889795133670. The nails have out-of-spec thread depths that may prevent proper mating with the mounting bolt, potentially requiring abortion of the planned surgery. The devices were distributed nationwide in the states NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA.
| Brand | 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. |
| Severity | moderate |
| Units affected | 1 |
| Distribution | US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. |
| Agency | FDA |
| Recall / campaign no. | UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030 |
WHAT YOU SHOULD DO
- Check with your surgeon if your procedure used or will use this nail (Lot 501182207125; UDI-DI 00889795133670) and discuss any needed changes.
- Do not attempt to adjust, remove, or repair the implant yourself; follow your healthcare provider's instructions.
- Contact your hospital or Paragon 28 for recall information and next steps, providing recall details (UDI-DI 00889795133670; Lot 501182207125).
- Seek medical attention promptly if you experience problems related to the implant or have upcoming surgery involving this device.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.