Limacorporate S.p.A

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
4
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2024-2025Class IIPRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, SterileMay 19, 2025
Z-2025-2025Class IIPRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, SterileMay 19, 2025
Z-0744-2025Class IITEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow SysOctober 2, 2024
Z-0524-2024Class IIPHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610October 27, 2023
Z-0726-2024Class IIPRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MAugust 29, 2023
Z-2009-2023Class IIREF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE RMay 30, 2023
Z-2010-2023Class IIREF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile RMay 30, 2023
Z-1317-2023Class IISMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210February 21, 2023
Z-1261-2023Class IITEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product lJanuary 25, 2023
Z-0160-2022Class IIREF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE October 1, 2021
Z-0159-2022Class IIREF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE October 1, 2021
Z-0068-2018Class IIDelta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the DeltSeptember 8, 2017
Z-2707-2016Class IISMR allen wrench 5 mm, product code 9013.50.210July 21, 2016
Z-1711-2016Class IISMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replApril 8, 2016
Z-2540-2015Class IISMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads August 14, 2015
Z-2539-2015Class IISMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial HAugust 14, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K243809Biolox® Delta Revision headsMarch 4, 2025
K213785SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented GlenoidMay 13, 2022
K211938Physica LMC Knee SystemJuly 13, 2021
K190911Physica KR Liner and SMR Reverse Humeral LinerNovember 26, 2019