Recall Z-2010-2023— Limacorporate S.p.A

Name: FDA recall Z-2010-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-30

Class II · Ongoing

Class II FDA medical device recall by Limacorporate S.p.A, initiated 2023-05-30. It names one FDA 510(k) clearance: K222427. Product: REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R. Reason: Due to manufacturing issue, their is a potential for peripheral holes to be out of specification..

Recalling firm: Limacorporate S.p.A
Classification: Class II
Status: Ongoing
Initiated: 2023-05-30
Firm location: San Daniele Del Friuli, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K222427 — PRIMA TT GlenoidLima Corporate S.P.A.·cleared 2022-10-06

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

REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R

Reason for recall

Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.

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