# FDA recall Z-1440-2021

> **Medtronic Sofamor Danek USA, Inc** · Class II · device recall initiated 2021-03-17.

## 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1440-2021
- **Recalling firm:** Medtronic Sofamor Danek USA, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-17
- **Report date:** 2021-04-28
- **Termination date:** 2023-05-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1440-2021

## Citation

> AI Analytics. FDA recall Z-1440-2021. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-1440-2021. Source: US FDA. Licensed CC0.

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