Medical device recalls Moderate risk

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalls Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Recall date
April 8, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1602-2016
FDA classification
Class II
Brand / firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Sold / distributed
Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.

Why it was recalled

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

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 Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

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