Recall Z-0213-05 ยท HBB Motor, Drill, Pneumatic
Power Surgical Solutions
Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas
| Date | Nov 20, 2004 (initiated Nov 3, 2004) |
| Status | Terminated |
| Reason | Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke). |
| Root cause | Other |
| Action | The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units. |
| Quantity | 12,286 cases of 4 units per case |
| Distribution | Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and 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 |