FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution: Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
- Recall number
- Z-1602-2016
- Recalling firm
- Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
- Product
- Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM. Intended for use in neurosurgery.
- Status
- Terminated
- Initiated
- 2016-04-08
- Posted
- 2016-05-04
- Terminated
- 2017-02-16
- Reason
- Incorrect color coding and attachment reference were included on the labeling of 10BA40D dissecting tools with lot number H5237248.
- Root cause
- Labeling mix-ups
- Action
- A notification letter was provided to each consignee, translated as necessary, on April 8, 2016.
- Quantity
- 81 tools
- Distribution
- Distributed in France, Ireland, Netherlands, Portugal, Switzerland, and United Kingdom.
- Lot, serial or model codes
- Product Catalog Number: 10BA40D, Lot Number: H5237248
- 510(k) numbers
- ["K020069"]
- PMA numbers
- not on file
- Product code
- HBB
- 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