Home / Recalls / Medtronic Sofamor Danek Usa, Inc - Dallas Distribution / Z-2085-2016

Z-2085-2016 Class II Terminated

Recalled by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution — Haltom City, TX

Recall Details

Product Type: Devices
Report Date: July 6, 2016
Initiation Date: May 13, 2016
Termination Date: June 13, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 368 devices

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.

Distribution Pattern

Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.

Code Information

All Serial Numbers.