---
title: "TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.0... — FDA record Z-0744-2025 | Is It on Recall"
description: "Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery."
url: https://isitonrecall.com/recall/fda-device-z-0744-2025-tema-elbow-axle-small-ref-1590-15-010-tema-elbow-axle-large-ref-1590-15-020-tema-elbow-system-is-a-c/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

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

# TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total... — FDA record Z-0744-2025

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 Oct 2, 2024. 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 Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
- **Reason**: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
- **Classification**: Class II
- **Recalling firm**: Limacorporate S.p.A
- **Quantity**: ~87 devices (U.S.)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0744-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0744-2025%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/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193 |

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

## Distribution

U.S: FL and TX O.U.S.: N/A

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

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

## Dates in the source

- **Report date**: Jan 1, 2025
- **Recall initiation date**: Oct 2, 2024
- **Center classification date**: Dec 20, 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-0744-2025%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/)