FDA Device recall Z-0744-2025
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
- FDA Device
- Class II
- ongoing
- Published 2025-01-01
On 2025-01-01 the FDA classified a Class II recall of 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 by Limacorporate S P A, citing due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0744-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-02 |
| Published | 2025-01-01 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Limacorporate S P A |
| Distribution | FL, TX |
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
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Identifiers
| code_info | Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 2303175230…Product/Catalog Numbers: 1590.15.010 TEMA ELBOW - AXLE SMALL UDI-DI code: 08033390128865 Lot/Serial Numbers: 23031752300054 23177372300230 23173852400087 Product/Catalog Number: 1590.15.020 TEMA ELBOW - AXLE LARGE UDI-DI code: 08033390128872 Lot/Serial Numbers: 22276962300054 23325482400047 24006192400193 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Limacorporate S P A
- PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
FDA Device · Class II · 2025-07-02 · Limacorporate S P A - PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
FDA Device · Class II · 2024-01-24 · Limacorporate S P A - PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
FDA Device · Class II · 2023-12-20 · Limacorporate S P A - REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R
FDA Device · Class II · 2023-07-05 · Limacorporate S P A
All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0744-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.