Class 2 Device Recall Saw Sagittal

• Date Initiated by Firm: May 13, 2016
• Date Posted: June 28, 2016
• Recall Status: Terminated on June 13, 2017
• Recall Number: Z-2085-2016
• Recall Event ID: 74275
• 510(K)Number: K081475
• Product Classification: Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
• 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.
• Code Information: All Serial Numbers.
• FEI Number: 1625507
• Recalling Firm/ Manufacturer: Medtronic Sofamor Danek Usa, Inc - Dallas Distribution; 4620 N Beach St; Haltom City TX 76137-3219
• For Additional Information Contact: 817-831-4181
• Manufacturer 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.
• FDA Determined Cause: Device Design
• Action: Recall notification letters were sent to consignees on 05/13/2016.
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HBE