Corin Ltd Recall 88589
Description: 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.
Corin Ltd Recall 88589 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2611-2021 |
| Event ID | 88589 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI. |
| Quantity | 2 units |
| Recall Reason | 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. |
| Device Classification | 20211006 |
| Device Code Info | 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. |
| Center Classification Date | 20210930 |
| Recall Initiation Date | 20210728 |
| Recalling Firm | Corin Ltd |
| Initial Notification | |
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