Paragon 28, Inc. has issued a recall for 20 Phantom Fibula Nails (2.8mm x 130mm, Right, Titanium) because the internal threads on the nails were manufactured outside of the required specifications. This defect means the nail implant may not connect properly with the mounting bolt and instrumentation used by surgeons. If this failure occurs during a procedure, the surgery may need to be stopped or aborted.
The improper thread depth prevents the surgical nail from mating correctly with its instrumentation, which can cause delays in treatment or result in an aborted surgical procedure for the patient.
Manufacturer initiated recall via notification letter.
Intended for use in fixation of fibular fractures and osteotomies.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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