Class II — Limacorporate S.p.A
| Recalling firm | Limacorporate S.p.A. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis. |
| Product | TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) |
| Quantity | 5 systems |
| Distribution | U.S. Distribution to: TX |
| Initiated | 2023-01-25 |
| Classified | 2023-03-16 |
| Recall number | Z-1261-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Limacorporate S.p.A (Z-1261-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91613/
Alerts for Limacorporate S.p.A.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.