FDA-Device2023-03-22Class II
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Limacorporate S.p.A
Hazard
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Sold states
U.S. Distribution to: TX
Affected count
5 systems
Manufactured in
Via Nazionale 52, Di San Daniele, San Daniele Del Friuli, N/A, Italy
Products
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2023Don't want to check this manually?
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