Fibula Nail Recall: Paragon 28 Phantom 2.8x130 Right Ti
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 |
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.
How to identify the recalled item
| Lot / date codes | UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030 |
|---|---|
| Lot / date codes | Lot Number AOCIA6123 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
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.