Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Saw Sagittal Catalog Number: ES 300 Recalled by Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Due to Medtronic Powered Surgical Solutions testing of the Sagittal...

Date: May 13, 2016
Company: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Sofamor Danek Usa, Inc - Dallas Distribution directly.

Affected Products

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.

Quantity: 368 devices

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 20 states: AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, MD, MA, NH, NY, NC, SC, TN, TX, UT

Affected (20 states)Not affected

About Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution has 3 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report