OrthoPediatrics Corp: Medical Device Recall in 2016 - (Recall #: Z-0879-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.
Product Description:

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

Product Classification:

Class III

Date Initiated: November 18, 2016
Date Posted: December 28, 2016
Recall Number: Z-0879-2017
Event ID: 75758
Reason for Recall:

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

Status: Terminated
Product Quantity: 22 units
Code Information:

Product Number: 10-1500-3048 Lot Number: 161421-G

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated