Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
FDA device recall Z-1602-2016 · posted 2016-05-04 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Reason for recall
- Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
- Action taken
- A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HBB
- Quantity affected
- 81 tools
- Distribution
- Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
- Date initiated
- 2016-04-08
- Date posted
- 2016-05-04
- Date terminated
- 2017-02-16
- Location
- Haltom City, TX
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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 |