Corin Ltd FDA Recalls

21 recalls on file across devices, 0 of them Class I and 5 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplastyClass IIOct 13, 2023Potential for Unity CR Inserts Right size 6 from batch 52980	Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts R	Class IIDevices	Oct 13, 2023
Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplastyClass IIOct 13, 2023Potential for Unity CR Inserts Right size 6 from batch 52980	Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labelled as Unity CR Inserts R	Class IIDevices	Oct 13, 2023
Corin BIOLOX DELTA MOD HEAD, 036mm EX LONG +8mm, REF 104.3615Class IINov 8, 2022The BIOLOX Delta Ceramic Head size 36XL is labelled as the s	The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.	Class IIDevices	Nov 8, 2022
Corin BIOLOX DELTA MOD HEAD,032mm, EX LONG +7mm, REF 104.3215Class IINov 8, 2022The BIOLOX Delta Ceramic Head size 36XL is labelled as the s	The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa.	Class IIDevices	Nov 8, 2022
Unity Total Knee System. Used for knee prosthesis in total knee replacementClass IIOct 31, 2022The internal packaging system for devices may have damage to	The internal packaging system for devices may have damage to the blisters potentially damaging the device or c	Class IIDevices	Oct 31, 2022
Corin METAFIX HIP STEM, SIZE 3, STANDARD, 135 degrees, COLLARED HIP STEM, CEMENTLESS, Part Number 579.0103Class IIJul 22, 2022One MetaFix size 7 collarless stem from batch 478179 which w	One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collar	Class IIDevices	Jul 22, 2022
TaperFit Stem, Size 0, 38mm OFFSET, 12/14 Taper + 188.550 Centraliser, For Cemented Use, REF 588.3800. Orthopedic hip iClass IIJul 12, 2022Some of the devices did not pass fatigue testing.	Some of the devices did not pass fatigue testing.	Class IIDevices	Jul 12, 2022
Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of tClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Trinity Liner ECIMA, diameter 40mm Neutral Offset, Taper Size 4, REF 322.04.640, Sterile; and Corin Trinity LinerClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.Class IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.Class IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Unity Knee Patella, Size 3 / 8.5mm, Centered Dome 3 PEG-UHMWPE, REF 112.018.06, Sterile, a component of the Unity Class IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Trinity Screw, diameter 6.5mm 35mm Length, Cancellous Bone Screw, REF 321.035, Sterile; and Corin Trinity Screw, dClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Trinity-i, diameter 50mm Taper Size 3, Non-Occluded Ti Plasma Shell, REF 320.03.350, Sterile, a component of the TClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Trinity Dual Mobility, Size 4, Dual Mobility CoCr Liner, REF 321.04.540, Sterile, and Corin Dual Mobility, Size 4 Class IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity AcClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWPE, REF 1125182, Sterile, and Corin Unity KClass IIJul 28, 2021The packaging system on the devices have potential physical	The packaging system on the devices have potential physical and water damage resulting in damage to the device	Class IIDevices	Jul 28, 2021
Corin TriFit CF SIZE 7, LATERALISED 127o, COMBINED FIXATION STEM, CEMENTLESS, REF 6961007. Hip prosthesis component.Class IIMay 6, 2021Units from one batch of TriFit TS size 2 stem were found to	Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice ve	Class IIDevices	May 6, 2021
Corin TriIFit TS SIZE 2, STANDARD TAPERED STEM, CEMENTLESS, REF 694.0002. Hip prosthesis component.Class IIMay 6, 2021Units from one batch of TriFit TS size 2 stem were found to	Units from one batch of TriFit TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice ve	Class IIDevices	May 6, 2021
Corin BIOLOX DELTA MOD HEAD 36mm EX LONG +8mm12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/Trinity Class IIJan 25, 2021The size indicated on the labeling on the outer packaging, o	The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers	Class IIDevices	Jan 25, 2021
Corin BIOLOX DELTA MOD HEAD 32mm EX LONG +7mm 12/14 TAPER. Corin Trinity Acetabular System with Extra Long Heads/TrinityClass IIJan 25, 2021The size indicated on the labeling on the outer packaging, o	The size indicated on the labeling on the outer packaging, on the inner packaging, and on the patient stickers	Class IIDevices	Jan 25, 2021