FDA-Device2025-01-01Class II
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
Hazard
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Sold states
U.S: FL and TX O.U.S.: N/A
Affected count
~87 devices (U.S.)
Manufactured in
Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, Italy
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0744-2025Don't want to check this manually?
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