FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA, Inc: Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
- Recall number
- Z-1440-2021
- Recalling firm
- Medtronic Sofamor Danek USA, Inc
- Product
- Endoskeleton TC Interbody System with Titan nanoLOCK Surface Technology, 6 Degree, Large, 8 mm, Product Number 5146-1608-N - Product Usage: indicated to be used with supplemental fixation cleared by the FDA for use in the cervical spine and autograft bone, allograft bone comprised of cancellous and/or corticocancellous bone, demineralized allograft with bone marrow aspirate, or a combination thereof.
- Status
- Terminated
- Initiated
- 2021-03-17
- Posted
- not on file
- Terminated
- 2023-05-03
- Reason
- The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
- Root cause
- Packaging process control
- Action
- The firm initiated the recall by letter on 03/19/2021, The letter requested that the consignee locate and isolate the impacted product and contact the Medtronic Sales Representative to coordinate the return and replacement of the device.
- Quantity
- 11 devices
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- GTIN 00191375013167, Lot Number TM0126572
- 510(k) numbers
- ["K141953","K183557","K192018"]
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3003120897
- Firm city
- Memphis
- Firm state
- TN
- 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