Medical device recalls Moderate risk

Medtronic Sofamor Danek USA Inc recalls VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

Recall date
March 26, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1941-2020
FDA classification
Class II
Brand / firm
Medtronic Sofamor Danek USA Inc
Sold / distributed
US Nationwide distribution in the states of CA and MI.

Why it was recalled

Nonconforming product; length of the product measured shorter than the labeled length.

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

What was recalled

VERTEX SELECT MULTI AXIAL SCREW. 4.0 X 38MM MULTI AXIAL SCREW. Lot H5517628

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