Endoskeleton TC Interbody System with Titan nanoLOCK Surface… — Class II medical device recall Z-1440-2021
Terminated recall by Medtronic Sofamor Danek USA, Inc, reported 2021-04-28, distributed nationwide. The shelf box identifies a small device actually contains a large device, and the shelf box identifying a larg
| Recall number | Z-1440-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Sofamor Danek USA, Inc, Memphis, TN, United States |
| Recall initiated | 2021-03-17 |
| Classified | 2021-04-20 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-05-03 |
| Distributed | Nationwide (US) |
| Quantity | 11 devices |
| UPC / GTIN / UDI-DI | 00191375013167 |
| Lot numbers | TM0126572 |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1440-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.