FDA Device recall Z-1261-2023
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
- FDA Device
- Class II
- ongoing
- Published 2023-03-22
On 2023-03-22 the FDA classified a Class II recall of TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling) by Limacorporate S P A, citing due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1261-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-01-25 |
| Published | 2023-03-22 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Limacorporate S P A |
| Distribution | TX |
Product
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Reason
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Identifiers
| code_info | Product Code: 1590.15.010 UDI-DI Code: 08033390128865 Lot Number: 2115522 Sterilization Lot Number: 2100241 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 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 - 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 · 2025-01-01 · 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
All Limacorporate S P A recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1261-2023%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.