FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: 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
- Recall number
- Z-2603-2018
- 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
- Status
- Terminated
- Initiated
- 2018-07-09
- Posted
- not on file
- Terminated
- 2021-05-07
- Reason
- 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
- 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 rs.sdmriskmgt@medtronic.com. 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
- 47 units
- Distribution
- US
- Lot, serial or model codes
- lot 0648247W
- 510(k) numbers
- ["K113174"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 1000477302
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28