Recall Z-1067-05 ยท HBB Motor, Drill, Pneumatic
Medtronic Powered Surgical Solutions
Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137.
| Date | Aug 3, 2005 (initiated Jun 29, 2005) |
| Status | Terminated |
| Reason | Complaints of finger control component breaking off and falling into open surgical wound. |
| Root cause | Other |
| Action | The firm initiated the recall via letter on July 1, 2005. |
| Quantity | 191 motors |
| Distribution | Nationwide. The device was distributed to hospitals and medical facilities in AL, AR, CA, CT, DC, DE, FL, HI, IA, IL, IN, ME, MN, MT, NC, NE, NJ, NM, NY, OH, PA, SC, TN, TX, and VA. Devices were also distributed to the following foreign countries: Japan, Mexico, Netherlands, Canada, 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 |