Device product
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Z-1602-2016
Product summary
- Event
- Event 73869
- Status
- Terminated
- Classification
- Class II
- Quantity
- 81 tools
- Official record key
device-enforcement:Z-1602-2016
Official wording
Reason: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Code information: Product Catalog Number: 10BA40D, Lot Number: H5237248
Distribution pattern: Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Derived failure modes
-
Unknown
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.