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Limacorporate S.p.A recalls TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Recalled March 22, 2023 · FDA recall Z-1261-2023 · 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. · FDA Class II
Units
5 systems
Sold at
U.S. Distribution to: TX
Description
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Product
TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Manufacturer(s)
Limacorporate S.p.A
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →