# FDA recall Z-1261-2023

> **Limacorporate S.p.A** · Class II · device recall initiated 2023-01-25.

## Product

TEMA Axle Small, REF 1590.15.010  (additional information is pending receipt of the firm's product label/labeling)

## Reason for recall

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

## Distribution

U.S. Distribution to: TX

## Key facts

- **Recall number:** Z-1261-2023
- **Recalling firm:** Limacorporate S.p.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-01-25
- **Report date:** 2023-03-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Daniele Del Friuli, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2023

## Citation

> AI Analytics. FDA recall Z-1261-2023. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1261-2023. Source: US FDA. Licensed CC0.

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