Z-0464-2012

CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l...

Name: Z-0464-2012 CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l...
Creator: Medtronic Sofamor Danek USA Inc
Published: 2011-11-30
License: https://open.fda.gov/license/

Medtronic Sofamor Danek USA Inc / initiated 2011-11-30 / Terminated

FDA source

Medtronic Sofamor Danek USA Inc began a recall of CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic... on 2011-11-30. The reason FDA records is "One screw may be longer then size etched on the screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0464-2012
Status: Terminated
Initiated: 2011-11-30
Posted: 2012-01-11
Terminated: 2012-04-05
Recalling firm: Medtronic Sofamor Danek USA Inc
Product: CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/DUAL LEAD THREAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X0809439, Rx only, Medtronic Sofamor Danek USA, 1800 Pyramid Place, Memphis, TN 38132 implantation
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: One screw may be longer then size etched on the screw.
FDA root cause: Mixed-up of materials/components
Action: Medtronic Sofamor Danek USA, Inc sent a Voluntary Field Correction letter dated November 30, 2011, via FedEx to all affected customers. The letter identified the product, the problem and the action needed to be taken by the customer. The firm will visit each consignee to perform a visual check of inventory. Please utilize the attached questionnare to account for the affected product and to record any patient injuries that may have occurred specifically related to the use of these items. If you need assistance, or if you have any related questions or concerns please call (800) 876-3133 extension 3173
Quantity in commerce: 252 units
Distribution: Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
Product codes and lots: Lot Numbers: 0132008W, 0150703W, 0150705W, and 0166823W

Product code KWQ

K042025Class IIModification to Cd Horizon Spinal SystemMedtronic Sofamor Danek, Inc. / cleared 2004-08-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)