FDA Device recall Z-0086-2022
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm by Medtronic Sofamor Danek Usa, citing engraving on implants may not match what is listed on the pouch labels.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0086-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-09-02 |
| Published | 2021-10-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Sofamor Danek Usa |
| Distribution | CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV |
Product
Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Reason
Engraving on implants may not match what is listed on the pouch labels.
Identifiers
| code_info | Product Number 5366-1410-N, Lot A200510 GTIN 00191375018490 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0086-2022%22
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