FDA recall Z-1261-2023

Limacorporate S.p.A · Class II · device

Product

TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

Reason for recall

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

Distribution

U.S. Distribution to: TX

Key facts

Status
Ongoing
Initiation date
2023-01-25
Report date
2023-03-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
San Daniele Del Friuli, N/A, Italy

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1261-2023