Medtronic Sofamor Danek USA Inc recalls Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as a…

Recall date

July 9, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2603-2018

FDA classification

Class II

Brand / firm

Medtronic Sofamor Danek USA Inc

Sold / distributed

US

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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