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

FDA device recall Z-0879-2017 · posted 2016-12-22 · Terminated

Recall details

Recalling firm

OrthoPediatrics Corp

Reason for recall

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

Action taken

OrthoPediatrics sent an URGENT MEDICAL DEVICE RECALL notification on November 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. . It is important that you carefully follow these recall instructions: " Please immediately take possession of any of these screws your customer may have or that you have, and quarantine them. Contact logistics@orthopediatrics.com to receive a Return Authorization Number. It is very important that we contain these devices rapidly and maintain them in quarantine. Replacement devices can be ordered from Customer Service. " The FedEx package you receive will contain a pre-addressed FedEx return label for the return of the recalled screw(s). " Included in this FedEx package is a Mandatory Reply Form for you to indicate the total number of affected screw(s) in your sets. We will be providing any additional follow up instructions as needed. If you have any questions call (574) 267-0865. For further questions regarding this recall , please call (574) 268-6379

Root cause

Labeling mix-ups

Status

Terminated

Product code

HSB

Quantity affected

22 units

Distribution

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

Date initiated

2016-11-18

Date posted

2016-12-22

Date terminated

2017-07-27

Location

Warsaw, IN

Related 510(k) clearances