FDA-Device2016-12-28Class III

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

OrthoPediatrics Corp
Hazard

Labeled as a 48mm Cortical Screw but measuring at 50mm

Sold states
Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.
Affected count
22 units
Manufactured in
2850 Frontier Dr, N/A, Warsaw, IN, United States
Products
OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0879-2017

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