Class II

Medical Device Recall: 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.

Limacorporate S.p.A · October 2, 2024

Reason for Recall

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

Distribution

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

States Affected

FL, TX

Quantity Affected

~87 devices (U.S.)

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0744-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.