Recall Z-0524-2024— Limacorporate S.p.A

Name: FDA recall Z-0524-2024
Creator: U.S. Food and Drug Administration
Published: 2023-10-27

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2023-10-27. It names one FDA 510(k) clearance: K213381. Product: PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610. Reason: Due to incorrect product labeling.

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2023-10-27
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K213381 — Physica systemLima Corporate S.P.A.·cleared 2021-12-17

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

PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

Reason for recall

Due to incorrect product labeling

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