Recall Z-2085-2016— Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Name: FDA recall Z-2085-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-13

Class II · Terminated

Class II FDA medical device recall by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution, initiated 2016-05-13, terminated 2017-06-13. It names one FDA 510(k) clearance: K081475. Product: Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.. Reason: Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use..

Recalling firm: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Classification: Class II
Status: Terminated
Initiated: 2016-05-13
Terminated: 2017-06-13
Firm location: Haltom City, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K081475 — ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)]Medtronic Xomed, Inc.·cleared 2008-10-17

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

Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.

Reason for recall

Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.

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