Paragon 28, Inc.: Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX, IL, OH, NV, TN, LA. Quantity: 20 Lot/code info: UDI-DI: 00889795133670. Lot: 501182207125. Expiration: March 13th, 2030

UPC codes

00889795133670, 501182207125

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.