Corin Ltd: The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.

Agency Publication Date: September 30, 2021

Affected Products

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 322.04.640 - Lot number 479381 was delivered 7/22/2021 and 7/23/2021; Model 322.04.936 - Lot number 479878 was delivered 7/22/2021 and 7/26/2021.

Lot Numbers:

number

Product: Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 467870 was delivered to the consignee on 7/23/2021 and 7/26/2021.

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.035 - Lot number 481070 was delivered 7/23/2021 and 7/26/2021; and Model 321.050 - Lot number 478892 was delivered 7/23/2021.

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 441120 was delivered to the consignee 7/23/2021 and 7/26/2021.

Lot Numbers:

number

Product: Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 483603 was delivered 7/23/2021.

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 321.04.540 - Lot number 478880 delivered 7/26/2021; Model 325.04.042- Lot number 480567 delivered 7/26/2021.

Lot Numbers:

number

Product: Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 476399 was delivered 7/22/2021 and 7/23/2021.

Lot Numbers:

number

Product: Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 472687 was delivered 7/23/2021.

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Model 1125182 - Lot number 477942 was delivered 7/22/2021; model 1125243 - Lot number 479310 was delivered 7/23/2021.

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 473755 was delivered 7/26/2021.

Lot Numbers:

number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88589

Status: Resolved

Manufacturer: Corin Ltd

Manufactured In: United Kingdom

Units Affected: 10 products (5; 6 units; 2 units; 5 units; 4; 2; 2 units; 1 unit; 2 units; 1 unit)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Numbers:

number

Product: Corin TriFit TS, Size 8, Standard Tapered Stem, REF 694.0008, Sterile.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 467870 was delivered to the consignee on 7/23/2021 and 7/26/2021.

Lot Numbers:

number

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 441120 was delivered to the consignee 7/23/2021 and 7/26/2021.

Lot Numbers:

number

Product: Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2805, Sterile, a component of the Trinity Acetabular System.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 483603 was delivered 7/23/2021.

Lot Numbers:

number

Lot Numbers:

number

Product: Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, REF 579.0201, Sterile.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 476399 was delivered 7/22/2021 and 7/23/2021.

Lot Numbers:

number

Product: Corin Unity Knee Augments, Size 5, 6 & 7 / 10mm Thick, Femoral Posterior Augment, REF 1122370, Sterile, a component of the Unity Total Knee System.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 472687 was delivered 7/23/2021.

Lot Numbers:

number

Lot Numbers:

number

Product: 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.

The affected products are shipment specific and were delivered to the consignee between 7/22-26/2021. Lot number 473755 was delivered 7/26/2021.

Lot Numbers:

number