Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge)
FDA device recall Z-0419-03 · posted 2003-01-09 · Terminated
Recall details
- Recalling firm
- Medtronics Midas Rex
- Reason for recall
- Lubricant leaking from motor after sterilization causing bleed-through sterilization wrap and/or excess lubricant in instrument case.
- Action taken
- Recall letter was sent on 11/11/2002 to all consignees requesting that the consignee contact the Medtronic Neurologic Technologies sales representative for replacement.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 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
- Date initiated
- 2002-11-11
- Date posted
- 2003-01-09
- Date terminated
- 2003-03-21
- 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 |