Z-0321-2016Class II

Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes

Name: Z-0321-2016 Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes
Creator: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Published: 2015-10-21
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2015-10-21 / Terminated / root cause: manufacturing process

FDA source

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution began a recall of Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes on 2015-10-21. FDA classified it as Class II and gives the reason as "The wire pass hole is not present on the tools". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0321-2016
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Posted: 2015-11-20
Terminated: 2016-06-24
Recalling firm: Medtronic Powered Surgical Solutions
Product: Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.
Product code: HBB Motor, Drill, Pneumatic
Reason for recall: The wire pass hole is not present on the tools.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: A recall letter was mailed to consignees on October 21, 2015.
Quantity in commerce: 9 pieces
Distribution: Distributed in the states of California, New York, and Texas and the country of Belgium.
Product codes and lots: Catalog Number: 16TA24, Lot Number: 0006936810

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0321-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0321-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-20

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)