---
title: "X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. — FDA record Z-0533-2022 | Is It on Recall"
description: "The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the inser"
url: https://isitonrecall.com/recall/fda-device-z-0533-2022-x060-0270-8mm-titanium-insert-axle-interspinous-fusion-system/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. — FDA record Z-0533-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Dec 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
- **Reason**: The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
- **Classification**: Class II
- **Recalling firm**: XTANT Medical
- **Quantity**: 24 devices
- **Agency-reported status**: Terminated
- **Source record identifier**: Z-0533-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0533-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

U.S.: CA, MI, NV, and TX O.U.S.: Portugal

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Feb 9, 2022
- **Recall initiation date**: Dec 29, 2021
- **Center classification date**: Jan 28, 2022
- **Termination date**: Jun 17, 2024

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0533-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [XTANT Medical records](https://isitonrecall.com/brand/xtant-medical/)