Z-2603-2018Class II

Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal...

Name: Z-2603-2018 Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2018-07-09
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2018-07-09 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek USA Inc began a recall of Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic... on 2018-07-09. FDA classified it as Class II and gives the reason as "This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2603-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-09
Posted: 2018-08-03
Terminated: 2021-05-07
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees, delivered 09 July 2018. The notice stated provided a list of Loaner kits where the screws may also be found and provided the following instructions: " Instructions to Customers: 1.) Please locate and remove the impacted product from normal storage locations. Do not use this product. 2.) Complete the enclosed Customer Confirmation Form and return via email to [email protected]. 3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product. Transmission of this Field Safety Notice: 1.) This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 2.) Please transfer this notice to other organizations on which this action has an impact. 3.) Please maintain a copy of this notice in your records."
Quantity in commerce: 47 units
Distribution: US
Product codes and lots: lot 0648247W

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2603-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2603-2018	Class II	Terminated	Voluntary: Firm initiated	2018-08-15	2018-08-03

Product code NKB

K113174Class IICd Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. / cleared 2011-11-21

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)