FDA Device recall Z-0321-2016
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool
- FDA Device
- Class II
- terminated
- Published 2015-12-02
On 2015-12-02 the FDA classified a Class II recall of Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool by Medtronic Sofamor Danek Usa Dallas Distribution, citing the wire pass hole is not present on the tools.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0321-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-10-21 |
| Published | 2015-12-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Sofamor Danek Usa Dallas Distribution |
| Distribution | CA, NY, TX |
Product
Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Reason
The wire pass hole is not present on the tools.
Identifiers
| code_info | Catalog Number: 16TA24, Lot Number: 0006936810 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0321-2016%22
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