OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
FDA Recall Z-0879-2017 · Posted 2016-12-22
Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeHSB
Date Initiated2016-11-18
Date Terminated2017-07-27
Product Quantity22 units
Reason for Recall
Labeled as a 48mm Cortical Screw but measuring at 50mm
Firm 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 [email protected] 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
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.