22 results
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35ms
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Sources: EU EUDAMED, US FDA
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Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.
FDA Enforcement
Class II
·Terminated·Corin Ltd·June 23, 2021
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103
FDA Enforcement
Class II
·Ongoing·Corin Ltd·August 17, 2022
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
FDA Enforcement
Class II
·Terminated·Corin Ltd·March 31, 2021
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Biolox Delta Ceramic Head (Generic Name: Hip Prosthesis). The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell; acetabular liners in neutral offset, +4mm offset, +4mm oblique, neutral 4mm EPW; and ceramic and CoCrMo modular heads. The ceramic and CoCrMo modular heads are compatible with Corin titanium femoral stems. The Trinity Biolox Ceramic heads are packaged in a double peel pouch configuration.
FDA Enforcement
Class II
·Terminated·Corin Ltd·March 31, 2021
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
FDA Enforcement
Class II
·Ongoing·Corin Ltd·November 8, 2023
Unity Total Knee System. Used for knee prosthesis in total knee replacement
FDA Enforcement
Class II
·Terminated·Corin Ltd·November 30, 2022
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.
FDA Enforcement
Class II
·Terminated·Corin Ltd·June 23, 2021
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity Liner ECIMA, diameter 36mm Neutral 4mm EPW, Taper Size 4 (Elevated Wall), REF 322.04.936, Sterile; both are components of the Trinity Acetabular System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, diameter 6.5mm 50mm Length, Cancellous Bone Screw, REF 321.050, Sterile, both are components of the Trinity Acetabular System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity Knee CS Insert, Size 8 / 10.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125243, Sterile, both are components of the Unity Total Knee System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615
FDA Enforcement
Class II
·Ongoing·Corin Ltd·December 28, 2022
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
FDA Enforcement
Class II
·Ongoing·Corin Ltd·November 8, 2023
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the Trinity Acetabular System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Total Knee System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 42 insert/28 head, REF 325.04.042, Sterile; both are components of the Trinity Dual Mobility System.
FDA Enforcement
Class II
·Terminated·Corin Ltd·October 6, 2021