Recall Z-0278-05 ยท HBB Motor, Drill, Pneumatic
Power Surgical Solutions
Medtronic Midas Rex Legend High Speed Pneumatic System
| Date | Dec 4, 2004 (initiated Nov 11, 2004) |
| Status | Terminated |
| Reason | Softer hose increases the propensity for outer exhaust hose to kink or become occluded as a result of clamping. Complaints of hose rupture/burst have been reported. |
| Root cause | Other |
| Action | The firm initiated the recall via letter on November 11, 2004. |
| Quantity | 1432 units |
| Distribution | Nationwide and to the following foreign countries; Australia; Japan; Canada, China; Netherlands; Columbia; Mexico; Argentina; Sweden; Poland; Spain; Germany; Great Britan; Chile; Switzerland; Venezuela |
| 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 |