[Recalled] Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery. — Incorrect color coding and attachment reference were included on the labeling o… | FDA 2016-04-08
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery. |
|---|---|
| Brand / manufacturer | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1602-2016 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 08 April 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.