Recall Z-2085-2016 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
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.
| Date | Jun 28, 2016 (initiated May 13, 2016) |
| Status | Terminated |
| Reason | Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use. |
| Root cause | Device Design |
| Action | Recall notification letters were sent to consignees on 05/13/2016. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081475 | ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] Medtronic Xomed, Inc., Oct 17, 2008 |