Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: Medical Device Recall in 2016 - (Recall #: Z-1602-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.

Product Classification:

Class II

Date Initiated: April 8, 2016

Date Posted: May 11, 2016

Recall Number: Z-1602-2016

Event ID: 73869

Reason for Recall:

Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.

Status: Terminated

Product Quantity: 81 tools

Code Information:

Product Catalog Number: 10BA40D, Lot Number: H5237248

Distribution Pattern:

Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated