Corin Ltd

FDA Regulatory Profile

Summary

Total Recalls
21
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0213-2024Class IIUnity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplaOctober 13, 2023
Z-0214-2024Class IIUnity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplastyOctober 13, 2023
Z-0726-2023Class IICorin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215November 8, 2022
Z-0727-2023Class IICorin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615November 8, 2022
Z-0273-2023Class IIUnity Total Knee System. Used for knee prosthesis in total knee replacementOctober 31, 2022
Z-1509-2022Class IICorin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 5July 22, 2022
Z-1667-2022Class IITaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.380July 12, 2022
Z-2604-2021Class IICorin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and CoJuly 28, 2021
Z-2612-2021Class IICorin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a comJuly 28, 2021
Z-2603-2021Class IICorin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.July 28, 2021
Z-2606-2021Class IICorin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; andJuly 28, 2021
Z-2609-2021Class IICorin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.July 28, 2021
Z-2607-2021Class IICorin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a componeJuly 28, 2021
Z-2611-2021Class IICorin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, SterileJuly 28, 2021
Z-2610-2021Class IICorin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, SteriJuly 28, 2021
Z-2605-2021Class IICorin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, July 28, 2021
Z-2608-2021Class IICorin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin DuJuly 28, 2021
Z-1851-2021Class IICorin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosMay 6, 2021
Z-1850-2021Class IICorin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.May 6, 2021
Z-1291-2021Class IICorin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with ExtraJanuary 25, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K201657Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip SyJuly 28, 2021
K200888OMNIBotics Knee SystemJune 27, 2020