TEMA Elbow — Class II medical device recall Z-0744-2025
Ongoing recall by Limacorporate S.p.A, reported 2025-01-01, distributed in FL, TX. Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revi
| Recall number | Z-0744-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele Del Friuli, Italy |
| Recall initiated | 2024-10-02 |
| Classified | 2024-12-20 |
| Reported by FDA | 2025-01-01 |
| Distributed | FL, TX |
| Quantity | 87 devices |
| UPC / GTIN / UDI-DI | 08033390128865, 08033390128872 |
| Serial numbers | 22276962300054, 23031752300054, 23173852400087, 23177372300230, 23325482400047, 24006192400193 |
| Model numbers | 1590.15.010, 1590.15.020 |
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 for recall
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0744-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.