Recall Z-0321-2016— Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Name: FDA recall Z-0321-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-21

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, initiated 2015-10-21, terminated 2016-06-24. It names one FDA 510(k) clearance: K020069. Product: Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes.. Reason: The wire pass hole is not present on the tools..

Recalling firm: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Classification: Class II
Status: Terminated
Initiated: 2015-10-21
Terminated: 2016-06-24
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

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

Reason for recall

The wire pass hole is not present on the tools.

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