FDA Device recall Z-0085-2022
Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
- FDA Device
- Class II
- terminated
- Published 2021-10-20
On 2021-10-20 the FDA classified a Class II recall of Endoskeleton" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm 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-0085-2022 |
| 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" TAS Interbody System with Titan nanoLOCK" Surface Technology, Nanolock 12 Dg Interbody, Large, 12mm
Reason
Engraving on implants may not match what is listed on the pouch labels.
Identifiers
| code_info | Product Number 2312-0212-N, Lot A200323 GTIN 00191375014171 |
|---|
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-0085-2022%22
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