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Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Recalls
3 recalls on record · December 2, 2015 to July 6, 2016 · Medical Devices
Recalls by year
15
16
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 6, 2016Medical DevicesFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalls Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Numb
Hazard: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
May 11, 2016Medical DevicesFDA
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalls Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Hazard: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
December 2, 2015Medical DevicesFDA
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.
Hazard: The wire pass hole is not present on the tools.