Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Numb
FDA device recall Z-2085-2016 · posted 2016-06-28 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- 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.
- Action taken
- Recall notification letters were sent to consignees on 05/13/2016.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HBE
- Quantity affected
- 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.
- Date initiated
- 2016-05-13
- Date posted
- 2016-06-28
- Date terminated
- 2017-06-13
- Location
- Haltom City, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] (K081475) | Medtronic Xomed, Inc. | 2008-10-17 |