Z-1602-2016 Class II Terminated
FDA device recall Z-1602-2016 was initiated by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution on April 8, 2016 and is designated Class II. Reason for recall: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248. The recall status is terminated (terminated February 16, 2017). Affected quantity: 81 tools.
Recall Details
- Product Type
- Devices
- Report Date
- May 11, 2016
- Initiation Date
- April 8, 2016
- Termination Date
- February 16, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
Code Information
Product Catalog Number: 10BA40D, Lot Number: H5237248