Recall Z-1574-05 ยท GET Motor, Surgical Instrument, Pneumatic Powered
Power Surgical Solutions
Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use Only.
| Date | Sep 21, 2005 (initiated Sep 1, 2005) |
| Status | Terminated |
| Reason | Potential compromise of sterile packaging for disposable dissecting tools. |
| Root cause | Other |
| Action | Firm notified consignees by letter on 9/1/2005. |
| Quantity | 3,522,710 units |
| Distribution | Nationwide and the following foreign countries: Aruba, Australia, Austria, Barbados, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, India, Iraq, Ir |
| 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 |
| K900388 | MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES Midas Rex Pneumatic Tools, Inc., May 7, 1990 |
| K952463 | GS & GS20 SURGICAL TOOL SYSTEM Midas Rex Pneumatic Tools, Inc., Jul 17, 1995 |
| K953432 | ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS Midas Rex Pneumatic Tools, Inc., Sep 14, 1995 |
| K953433 | MIDAS REX TELESCOPING SYSTEM Midas Rex Pneumatic Tools, Inc., Sep 15, 1995 |