Paragon 28 recalled 20 units of its fibula nail system on October 13, 2025. The recall affects devices with out-of-specification thread depths, risking surgical complications. Patients and healthcare providers must stop using the affected devices immediately.
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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The recalled product is the Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, REF: P36-128-130R-S. It was distributed nationwide in states including NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, and LA.
The fibula nail system may not properly mate with the associated mounting bolt due to out-of-specification thread depths. This can lead to the necessity of aborting surgery if the implant fails to function as intended.
The recall is classified as Class II but does not specify any reported injuries or incidents. The potential risk is significant given the nature of the device and its use in surgical procedures.
Patients and healthcare providers should stop using the product immediately. Follow the recall instructions from the manufacturer and contact Paragon 28, Inc. or a healthcare provider for further guidance.
For more information, contact Paragon 28, Inc. Please refer to the recall notice available at the FDA website for detailed instructions.
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