BEUDAMED
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    PRIMA 2MM ECCENTRICAL ADAPTOR WITH SCREW REF: 1367.15.702, Sterile

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 2, 2025

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

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 2, 2025

    TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·January 1, 2025

    SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·June 1, 2016

    SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    SMR allen wrench 5 mm, product code 9013.50.210

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 7, 2016

    SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·September 9, 2015

    Delta Cup Beater  Positioner - Aligner, model # 9057.20.555 Used during implantation of the Delta Acetabular System

    FDA Enforcement
    Class II ·Completed·Limacorporate S.p.A·November 15, 2017

    TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·March 22, 2023

    PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·December 20, 2023

    REF 1975.14.500, Prima TT Genoid Monoblock Reverse TT Baseplate, STERILE R

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 5, 2023

    SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·April 5, 2023

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

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·July 5, 2023

    PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM REGULAR/1975.14.800, BASEPLATE D.25MM FULL WEDGED 10-degrees/1975.14.510, BASEPLATE D.28MM FULL WEDGED 10-degrees/1975.14.810, BASEPLATE D.25MM FULL WEDGED 15-degrees/1975.14.615, BASEPLATE D.28MM FULL WEDGED 15-degrees/1975.14.815, BASEPLATE D.28MM FULL WEDGED 15-degrees X/1975.14.865, BASEPLATE D.25 MM FULL WEDGED 20-degrees/1975.14.620, BASEPLATE D.28 MM FULL WEDGED 20-degrees/1975.14.820, BASEPLATE D.28 MM FULL WEDGED 20-degrees X/1975.14.870

    FDA Enforcement
    Class II ·Ongoing·Limacorporate S.p.A·January 24, 2024

    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021

    REF 8420.15.020, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=25mm, STERILE R, 2100099, UDI: (01)08033390018852

    FDA Enforcement
    Class II ·Terminated·Limacorporate S.p.A·October 27, 2021