Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalls Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
- Recall date
- October 21, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0321-2016
- FDA classification
- Class II
- Brand / firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Sold / distributed
- Distributed in the states of California, New York, and Texas and the country of Belgium.
Why it was recalled
The wire pass hole is not present on the tools.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
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