FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-2085-2016
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- 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.
- Status
- Terminated
- Initiated
- 2016-05-13
- Posted
- 2016-06-28
- Terminated
- 2017-06-13
- 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.
- Lot, serial or model codes
- All Serial Numbers.
- 510(k) numbers
- ["K081475"]
- PMA numbers
- not on file
- Product code
- HBE
- Firm FEI
- 1625507
- Firm city
- Haltom City
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28