Medtronic Sofamor Danek USA Inc recalls Medtronic ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixatio…

Recall date

March 23, 2018

Source

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

Recall number

Z-1750-2018

FDA classification

Class II

Brand / firm

Medtronic Sofamor Danek USA Inc

Sold / distributed

Worldwide Distribution - US Nationwide in the states of GA, CT, LA, MD, WY, IN, MD, FL, and France

Why it was recalled

Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.

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 ZEVO(TM) Anterior Cervical Plate System SLOT SCREW, REF 7710015, Size 4.5mm x 15mm Product Appliance, fixation, spinal intervertebral body