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U.S. Department of Health and Human Services

Class 3 Device Recall OrthoPediatrics PediNail Intramedullary Nailing System

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  Class 3 Device Recall OrthoPediatrics PediNail Intramedullary Nailing System see related information
Date Initiated by Firm November 18, 2016
Date Posted December 22, 2016
Recall Status1 Terminated 3 on July 27, 2017
Recall Number Z-0879-2017
Recall Event ID 75758
510(K)Number K083726  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product OrthoPediatrics PediNail Intramedullary Nailing System
4.5mm X 48mm Cortical Screw
Code Information Product Number: 10-1500-3048 Lot Number: 161421-G
Recalling Firm/
Manufacturer		 OrthoPediatrics Corp
2850 Frontier Dr
Warsaw IN 46582-7001
For Additional Information Contact Greg Teghtmeyer
574-268-6379
Manufacturer Reason
for Recall		 Labeled as a 48mm Cortical Screw but measuring at 50mm
FDA Determined
Cause 2		 Labeling mix-ups
Action 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
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ORTHOPEDIATRICS, CORP.
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