Recall Z-0419-03 ยท HBB Motor, Drill, Pneumatic
Medtronics Midas Rex
Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
| Date | Jan 9, 2003 (initiated Nov 11, 2002) |
| Status | Terminated |
| Reason | Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case. |
| Root cause | Other |
| Action | Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement. |
| Quantity | PA100-94 cs, PM100-71ea, PM110-5 ea, PM200-24 ea |
| Distribution | Nationwide: CA, OH, FL, PA, GA, AZ, LA, MI, TX, NJ, NM, NC, VA, WA, NE, AL, NY, TN |
| 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 |