Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: Medical Device Recall in 2016 - (Recall #: Z-2085-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 13, 2016

Date Posted: July 6, 2016

Recall Number: Z-2085-2016

Event ID: 74275

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.

Status: Terminated

Product Quantity: 368 devices

Code Information:

All Serial Numbers.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated