Recall Z-0321-2016 ยท HBB Motor, Drill, Pneumatic
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
| Date | Oct 21, 2015 |
| Status | Terminated |
| Reason | The wire pass hole is not present on the tools. |
| Root cause | Process control |
| Action | A recall letter was mailed to consignees on October 21, 2015. |
| Quantity | 9 pieces |
| Distribution | Distributed in the states of California, New York, and Texas and the country of Belgium. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020069 | MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM Medtronic Midas Rex, Mar 18, 2002 |