Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
FDA Device Recall #Z-1602-2016 — Class II — April 8, 2016
Recall Summary
| Recall Number | Z-1602-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 8, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution |
| Location | Haltom City, TX |
| Product Type | Devices |
| Quantity | 81 tools |
Product Description
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Reason for Recall
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Distribution Pattern
Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Lot / Code Information
Product Catalog Number: 10BA40D, Lot Number: H5237248
Other Recalls from Medtronic Sofamor Danek Usa, Inc - Da...
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2085-2016 | Class II | Saw Sagittal Catalog Number: ES 300; Saw Sagitt... | May 13, 2016 |
| Z-0321-2016 | Class II | Tool Legend 16cm 2.4 mm wire pass for Midas Rex... | Oct 21, 2015 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.