Paragon 28, Inc.
4 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Paragon 28, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-12-10FDA-DeviceClass IIPhantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
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.
- 2024-03-13FDA-DeviceClass IIPhantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Medical devices distributed, prior to sterilization
- 2024-03-13FDA-DeviceClass IIPhantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Medical devices distributed, prior to sterilization
- 2024-03-13FDA-DeviceClass IIPhantom TTC Nail, 10.0 X 200mm, Right
Medical devices distributed, prior to sterilization
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