TEMA Axle Small — Class II medical device recall Z-1261-2023
Ongoing recall by Limacorporate S.p.A, reported 2023-03-22, distributed in TX. Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow pr
| Recall number | Z-1261-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Limacorporate S.p.A, San Daniele Del Friuli, N/A, Italy |
| Recall initiated | 2023-01-25 |
| Classified | 2023-03-16 |
| Reported by FDA | 2023-03-22 |
| Distributed | TX |
| Quantity | 5 systems |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 08033390128865 |
| Lot numbers | 2100241, 2115522 |
| Model numbers | 1590.15.010 |
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.
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-1261-2023. 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.