Home / Recalls / Medical Devices
Medtronic Sofamor Danek USA Inc recalls Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an
Recalled August 15, 2018 · FDA recall Z-2603-2018 · Medtronic Sofamor Danek USA
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. · FDA Class II
Units
47 units
Sold at
US
Description
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.
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
Manufacturer(s)
Medtronic Sofamor Danek USA Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →