FDA Device recall Z-1602-2016
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery
- FDA Device
- Class II
- terminated
- Published 2016-05-11
On 2016-05-11 the FDA classified a Class II recall of Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery by Medtronic Sofamor Danek Usa Dallas Distribution, citing incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1602-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2016-05-11 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Medtronic Sofamor Danek Usa Dallas Distribution |
| Distribution | n/a |
Product
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Reason
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Identifiers
| code_info | Product Catalog Number: 10BA40D, Lot Number: H5237248 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1602-2016%22
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