FDA recall Z-0744-2025

Limacorporate S.p.A · Class II · device

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 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

Key facts

Status
Ongoing
Initiation date
2024-10-02
Report date
2025-01-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Daniele Del Friuli, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2025