medical Class II Updated 2018-08-15

Medtronic Sofamor Danek USA Inc recalls Medtronic CD HORIZON Spinal System is intended to help provi

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: US
Lot/Code Info: lot 0648247W
View official government recall

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