FDA-Device2018-08-15Class II
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
Medtronic Sofamor Danek USA Inc
Hazard
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.
Sold states
US
Affected count
47 units
Manufactured in
1800 Pyramid Pl, N/A, Memphis, TN, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2603-2018Don't want to check this manually?
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