Recall Z-1602-2016 ยท HBB Motor, Drill, Pneumatic
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
| Date | May 4, 2016 (initiated Apr 8, 2016) |
| Status | Terminated |
| Reason | Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248. |
| Root cause | Labeling mix-ups |
| Action | A notification letter was provided to each consignee, translated as necessary, on April 8, 2016. |
| Quantity | 81 tools |
| Distribution | Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom. |
| 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 |