Z-1602-2016Class II

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

Name: Z-1602-2016 Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery
Creator: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Published: 2016-04-08
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2016-04-08 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution began a recall of Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery on 2016-04-08. FDA classified it as Class II and gives the reason as "Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1602-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Posted: 2016-05-04
Terminated: 2017-02-16
Recalling firm: Medtronic Powered Surgical Solutions
Product: Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
Quantity in commerce: 81 tools
Distribution: Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
Product codes and lots: Product Catalog Number: 10BA40D, Lot Number: H5237248

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1602-2016	Class II	Terminated	Voluntary: Firm initiated	2016-05-11	2016-05-04

Product code HBB

K020069Class IIMedtronic Mida Rex Legend System, Midas Rex Legend Pneumatic High Speed System or Legend SystemMedtronic Midas Rex / cleared 2002-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)