Limacorporate S.p.A recalls TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented to

Recalled January 1, 2025 · FDA recall Z-0744-2025 · Limacorporate S.p.A

Hazard

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

Units

~87 devices (U.S.)

Sold at

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

Description

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.

Manufacturer(s)

Limacorporate S.p.A

Made in

Italy

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →