Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic CD HORIZON Spinal System is intended to help provide Recalled by Medtronic Sofamor Danek USA Inc Due to This lot has incorrectly been laser marked both...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek USA Inc directly.
Affected Products
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
Quantity: 47 units
Why Was This Recalled?
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.
Where Was This Sold?
US
About Medtronic Sofamor Danek USA Inc
Medtronic Sofamor Danek USA Inc has 81 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report