FDA Medical Device Recalls (openFDA)
Medtronic Sofamor Danek USA Inc: Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
- Recall number
- Z-0086-2022
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Product
- Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
- Status
- Terminated
- Initiated
- 2021-09-02
- Posted
- not on file
- Terminated
- 2023-10-05
- Reason
- Engraving on implants may not match what is listed on the pouch labels.
- Root cause
- Packaging change control
- Action
- A customer letter was sent via FedEx to impacted US consignees and delivered on or about September 3, 2021. Customers are asked to locate and remove the impacted product from normal storage locations. Customers are advised to not use product. A Customer Confirmation Form should be completed and returned to rs.sdmriskmgt@medtronic.com. Customers may also coordinate return and replacement of impacted product with the Medtronic Sales Representative. This recall notice should be forwarded to those within the customer organization or to any organization where potentially impacted devices have been transferred.
- Quantity
- 9 units
- Distribution
- Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV
- Lot, serial or model codes
- Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490
- 510(k) numbers
- ["K151596","K153122","K173535","K183557","K191565","K192018"]
- PMA numbers
- not on file
- Product code
- OVE
- Firm FEI
- 1000477302
- 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