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 a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery. |
| 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. |
| Quantity | ~87 devices (U.S.) |
| Distribution | U.S: FL and TX O.U.S.: N/A |
| Initiated | 2024-10-02 |
| Classified | 2024-12-20 |
| Recall number | Z-0744-2025 |
| 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-0744-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95732/
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