Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4
FDA device recall Z-1574-05 · posted 2005-09-21 · Terminated
Recall details
- Recalling firm
- Power Surgical Solutions
- Reason for recall
- Potential compromise of sterile packaging for disposable dissecting tools.
- Action taken
- Firm notified consignees by letter on 9/1/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- GET
- Quantity affected
- 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
- Date initiated
- 2005-09-01
- Date posted
- 2005-09-21
- Date terminated
- 2007-07-25
- Location
- Fort Worth, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM (K020069) | Medtronic Midas Rex | 2002-03-18 |
| MIDAS REX TELESCOPING SYSTEM (K953433) | Midas Rex Pneumatic Tools, Inc. | 1995-09-15 |
| ROTATING, FIXED FOOTED, FIXED SHIELD ATTACHMENTS, DISSECTING TOOLS (K953432) | Midas Rex Pneumatic Tools, Inc. | 1995-09-14 |
| GS & GS20 SURGICAL TOOL SYSTEM (K952463) | Midas Rex Pneumatic Tools, Inc. | 1995-07-17 |
| MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES (K900388) | Midas Rex Pneumatic Tools, Inc. | 1990-05-07 |