Medtronic Sofamor Danek Usa, Inc - Dallas Distribution recalls Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Numb

Recalled July 6, 2016 · FDA recall Z-2085-2016 · Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Hazard

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 Class II

Units

368 devices

Sold at

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.

Description

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

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.

Manufacturer(s)

Medtronic Sofamor Danek Usa, Inc - Dallas Distribution

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →