Recall Z-2025-2025— Limacorporate S.p.A

Name: FDA recall Z-2025-2025
Creator: U.S. Food and Drug Administration
Published: 2025-05-19

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2025-05-19. It names one FDA 510(k) clearance: K212800. Product: PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile. Reason: There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2025-05-19
Firm location: San Daniele Del Friuli, Italy

510(k) clearances named in this recall

1 on FDA's record

K212800 — PRIMA Humeral System and SMR Glenosphere Ø42Lima Corporate S.P.A.·cleared 2022-02-25

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

PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile

Reason for recall

There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.

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