---
title: "TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt o... — FDA record Z-1261-2023 | Is It on Recall"
description: "Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis."
url: https://isitonrecall.com/recall/fda-device-z-1261-2023-tema-axle-small-ref-1590-15-010-additional-information-is-pending-receipt-of-the-firm-s-product-labe/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) — FDA record Z-1261-2023

Reported ongoing

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 Jan 25, 2023. 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**: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- **Reason**: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
- **Classification**: Class II
- **Recalling firm**: Limacorporate S.p.A
- **Quantity**: 5 systems
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1261-2023

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1261-2023%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 | Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241 |

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

## Distribution

U.S. Distribution to: TX

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

- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Mar 22, 2023
- **Recall initiation date**: Jan 25, 2023
- **Center classification date**: Mar 16, 2023

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-1261-2023%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Limacorporate S.p.A records](https://isitonrecall.com/brand/limacorporate-s-p-a/)