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

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0879-2017

FDA classification

Class III

Brand / firm

OrthoPediatrics Corp

Sold / distributed

Worldwide Distribution - US Distribution to the states of : TX, MO, FL, GA, NC, AZ, NY., and to the countries of France and Ireland.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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