FDAFDA · Food and drugs·Recall number Z-1602-2016
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Published May 11, 2016 · Recall initiated: April 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Distributor
- Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
- Lot
- Product Catalog Number: 10BA40D, Lot Number: H5237248
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States