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All product recalls associated with Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062.
Total Recalls
7
Past Year
1
Class I (Serious)
0
Most Recent
Oct 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
Medical devices distributed, prior to sterilization
Medical devices distributed, prior to sterilization