Skip to content

Saw Sagittal Catalog Number: ES 300 recallZ-2085-2016 · Medtronic Sofamor Danek Usa, Inc - Dallas Distribution · initiated May 13, 2016

Class II Terminated All recalls posted in June 2016

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Sofamor Danek Usa, Inc - Dallas Distribution or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Device Design

What the company is doing

Recall notification letters were sent to consignees on 05/13/2016.

Recall details

Recall number
Z-2085-2016
Recall class
Class II
Status
Terminated
Initiated by the company
May 13, 2016
Posted by the FDA
Jun 28, 2016
Recalling firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Quantity
368 devices
Product code
HBE
FDA submissions
K081475
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 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.

Code information (models, lots, serial numbers)

All Serial Numbers.

Other devices under the same FDA submission

30 devices cleared under K081475 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page