Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgi
FDA device recall Z-0213-05 · posted 2004-11-20 · Terminated
Recall details
- Recalling firm
- Power Surgical Solutions
- Reason for recall
- Reduced plastic thickness of lubricant/diffuser cartidge can crack under pressure causing leakage of lubricant as visible mist (appearance of smoke).
- Action taken
- The firm initiated the recall by letter on November 3, 2004 asking consignees to return unused units.
- Root cause
- Other
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 12,286 cases of 4 units per case
- Distribution
- Product was shipped nationwide and to the following foreign countries: Australia, Canada, Hong Kong, Japan, Netherlands, Columbia, Chile, and Venezuela.
- Date initiated
- 2004-11-03
- Date posted
- 2004-11-20
- Date terminated
- 2005-11-03
- Location
- Fort Worth, TX
Monitor recalls programmatically
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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 |