CD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm… recallZ-0464-2012 · Medtronic Sofamor Danek USA Inc · initiated Nov 30, 2011
Terminated All recalls posted in January 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Sofamor Danek USA Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
One screw may be longer then size etched on the screw.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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
Recall details
- Recall number
- Z-0464-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 30, 2011
- Posted by the FDA
- Jan 11, 2012
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Quantity
- 252 units
- Product code
- KWQ
- FDA submissions
- K042025
- Distribution
- Nationwide Distribution including the states of AL, PA, IN, CO, MI and IA.
Product description
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
Code information (models, lots, serial numbers)
Lot Numbers: 0132008W, 0150703W, 0150705W, and 0166823W
Other devices under the same FDA submission
26 devices cleared under K042025 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- CD HORIZON® Spinal System 75446540Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION22 reports
- CD HORIZON® Spinal System 75446545Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation21 reports
- CD HORIZON® Spinal System 75445540Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY15 reports
- CD HORIZON® Spinal System 75446550Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY12 reports
- CD HORIZON® Spinal System X0311334Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION6 reports
- CD HORIZON® Spinal System 75445545Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL5 reports
- CD HORIZON® Spinal System 75446535Medtronic Sofamor Danek, Inc. · Orthosis, spondylolisthesis spinal fixation5 reports
- CD HORIZON® Spinal System 75447540Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERLAMINAL4 reports
- CD HORIZON® Spinal System 75496540Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION4 reports
- CD HORIZON® Spinal System 75445535Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY3 reports
- CD HORIZON® Spinal System 75496545Medtronic Sofamor Danek, Inc. · ORTHOSIS, SPINAL PEDICLE FIXATION3 reports
- CD HORIZON® Spinal System 75445530Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY2 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 60568).
- Z-0465-2012 · TerminatedCD HORIZON (R) Spinal System, MULTI-AXIAL SCREW FOR 5.5mm ROD W/REDUCTION HEAD, Size 6.5mm X 40mm, Mat'l TITANIUM ALLOY, REF X1010484, Rx only, Medtronic Sofamor Danek USA, 1800 Py…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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