Paragon 28 recalled 20 Phantom Fibula Nails nationwide after finding out-of-spec thread depths. The defect may prevent the nail from mating properly with the mounting bolt. Surgery could be aborted if the implant cannot mate with instrumentation. Hospitals and surgeons should stop using the device immediately and follow recall instructions.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Paragon 28, Inc. or your healthcare provider for instructions. Notification method: Letter
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Fibula nails are implanted to fix fibular fractures or perform osteotomies. The Phantom Fibula Nail by Paragon 28 is titanium and designed for use in orthopedic surgery.
Out-of-spec thread depths may prevent proper mating with the mounting bolt. If the nail cannot mate with instrumentation, the surgery potentially will be aborted and the procedure may need to be redone.
This recall is not stated as part of a broader industry pattern.
Clinicians may need to alter surgical plans or abort procedures. No injuries or incidents have been reported to date.
See FDA recall page linked in notice for official instructions. Manufacturer contact is Paragon 28, Inc.
No specific replacement timeline provided. Follow manufacturer and healthcare provider instructions.
Retain the recall notification letter, document unit numbers and lot numbers, keep correspondence with providers and manufacturers.
Model numbers: UDI-DI 00889795133670. Lot: 501182207125. Expiration: March 13th. Additional model: 2030. Distribution: US nationwide in NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. Manufacturer: Paragon 28, Inc. Recall date: 2025-10-13. Status: ACTIVE. Quantity: 20.
No injuries or incidents have been reported.
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