Limacorporate S.p.A: Medical Device Recall in 2025 - (Recall #: Z-0744-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: October 2, 2024

Date Posted: January 1, 2025

Recall Number: Z-0744-2025

Event ID: 95732

Reason for Recall:

Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.

Status: Ongoing

Product Quantity: ~87 devices (U.S.)

Code Information:

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

Distribution Pattern:

U.S: FL and TX O.U.S.: N/A

Voluntary or Mandated:

Voluntary: Firm initiated