Z-0879-2017Class III

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

Name: Z-0879-2017 OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Creator: OrthoPediatrics Corp
Published: 2016-11-18
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2016-11-18 / Terminated / root cause: labeling and UDI

FDA source

OrthoPediatrics Corp began a recall of OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw on 2016-11-18. FDA classified it as Class III and gives the reason as "Labeled as a 48mm Cortical Screw but measuring at 50mm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0879-2017
Classification: Class III
Status: Terminated
Initiated: 2016-11-18
Posted: 2016-12-22
Terminated: 2017-07-27
Recalling firm: Orthopediatrics Corp
Product: OrthoPediatrics PediNail Intramedullary Nailing System 4.5mm X 48mm Cortical Screw
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: Labeled as a 48mm Cortical Screw but measuring at 50mm
Root cause tag: labeling and UDI
FDA root cause: 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 [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
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.
Product codes and lots: Product Number: 10-1500-3048 Lot Number: 161421-G

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0879-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0879-2017	Class III	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-22

Product code HSB

K083726Class IIPedinail Intramedullary Nailing SystemOrthoPediatrics Corp. / cleared 2009-03-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)