Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23 Medtronic Powered Surgical Solutions, Forth Worth, TX
FDA device recall Z-2156-2008 · posted 2008-08-23 · Terminated
Recall details
- Recalling firm
- Medtronic Powered Surgical Solutions
- Reason for recall
- Cutting flute geometry of surgical dissecting tools may be outside of established tolerance. This may lead to reduced cutting performance, inability to perform desired dissection, increased risk of overheating, and potential need for revision surgery.
- Action taken
- Firm notified consignees by Urgent: Medical Device Recall letter sent May 30, 2008. The letter requires consignees to immediately compare their inventory of products against the list provided and quarantine any unused dissecting tools. The letter also states that Medtronic would provide replacement product to match the quantity and type returned by the consignees' institution.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 1,306 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2008-05-30
- Date posted
- 2008-08-23
- Date terminated
- 2009-08-22
- 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 |