FDA Enforcement
Class II
Terminated
Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Recall: Z-1602-2016
·
Reported May 11, 2016
Enforcement
- Recall Number
- Z-1602-2016
- Event ID
- 73869
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 11, 2016
- Initiation Date
- April 8, 2016
- Classification Date
- May 4, 2016
- Termination Date
- February 16, 2017
- Address
- 4620 N Beach St, Haltom City, TX, 76137-3219, United States
Description
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.
Code Info
Product Catalog Number: 10BA40D, Lot Number: H5237248
Distribution
Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Quantity
81 tools