Z-2085-2016Class II

Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger...

Name: Z-2085-2016 Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger...
Creator: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Published: 2016-05-13
License: https://open.fda.gov/license/

Medtronic Powered Surgical Solutions / initiated 2016-05-13 / Terminated / root cause: design

FDA source

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution began a recall of Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger... on 2016-05-13. FDA classified it as Class II and gives the reason as "Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2085-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-13
Posted: 2016-06-28
Terminated: 2017-06-13
Recalling firm: Medtronic Powered Surgical Solutions
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.
Product code: HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
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.
Root cause tag: design
FDA root cause: Device Design
Action: Recall notification letters were sent to consignees on 05/13/2016.
Quantity in commerce: 368 devices
Distribution: 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.
Product codes and lots: All Serial Numbers.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2085-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2085-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-28

Product code HBE

K081475Class IIElectric Drill System [Xps 4000 System, Midas Rex Legend Ehs System, Integrated Power Console (Ipc)]Medtronic Xomed, Inc. / cleared 2008-10-17

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)