Home / Companies / Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2085-2016Class IISaw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital,May 13, 2016
Z-1602-2016Class IIMedtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.April 8, 2016
Z-0321-2016Class IITool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill October 21, 2015