FDAClass IIJuly 6, 2016

Saw Sagittal recall

Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital…

Why was Saw Sagittal 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Serial Numbers.

Product
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital…
Recalling firm
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Quantity
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.
Recall date
July 6, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls