Recall Z-1261-2023— Limacorporate S.p.A

Name: FDA recall Z-1261-2023
Creator: U.S. Food and Drug Administration
Published: 2023-01-25

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2023-01-25. It names one FDA 510(k) clearance: K181362. Product: TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling). Reason: Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2023-01-25
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K181362 — TEMA Elbow SystemLima Corporate S.P.A.·cleared 2019-02-16

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 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.

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