Limacorporate S.p.A: Device Recall

Recall #Z-0744-2025 · 10/02/2024

Class II: Risk

Recall Details

Recall Number: Z-0744-2025
Classification: Class II
Product Type: Device
Recalling Firm: Limacorporate S.p.A
Status: Ongoing
Date Initiated: 10/02/2024
Location: San Daniele Del Friuli, Italy
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: ~87 devices (U.S.)

Reason for Recall

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

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.

Distribution Pattern

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

Other Recalls by Limacorporate S.p.A

Class II: Risk 05/19/2025

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class II: Risk 05/19/2025

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

View all recalls by Limacorporate S.p.A →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.