Recall Z-1602-2016— Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Name: FDA recall Z-1602-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-08

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, initiated 2016-04-08, terminated 2017-02-16. It names one FDA 510(k) clearance: K020069. Product: Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.. Reason: Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248..

Recalling firm: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Classification: Class II
Status: Terminated
Initiated: 2016-04-08
Terminated: 2017-02-16
Firm location: Haltom City, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K020069 — MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEMMedtronic Midas Rex·cleared 2002-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.