Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw Recalled by OrthoPediatrics Corp Due to Labeled as a 48mm Cortical Screw but measuring...

Date: November 18, 2016
Company: OrthoPediatrics Corp
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact OrthoPediatrics Corp directly.

Affected Products

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

Quantity: 22 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 7 states: AZ, FL, GA, MO, NY, NC, TX

Affected (7 states)Not affected

About OrthoPediatrics Corp

OrthoPediatrics Corp has 26 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report