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

Recall Insight

This FDA Devices action (record #Z-1602-2016) was formally reported on May 11, 2016, with the manufacturer initiating the action on April 8, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Medtronic Sofamor Danek Usa, Inc - Dallas Distribution is listed as the recalling firm, operating out of Haltom City, TX. Federal records indicate 81 tools units are affected.

The documented reason for this recall is: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248. Distribution data in the federal record shows the product reached: Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.