Recall Z-0744-2025— Limacorporate S.p.A

Name: FDA recall Z-0744-2025
Creator: U.S. Food and Drug Administration
Published: 2024-10-02

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2024-10-02. It names one FDA 510(k) clearance: K222807. 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: Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2024-10-02
Firm location: San Daniele Del Friuli, Italy

510(k) clearances named in this recall

1 on FDA's record

K222807 — TEMA Elbow system - Line extensionLima Corporate S.P.A.·cleared 2022-10-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.