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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2611-2021
Event ID88589
Event DescriptionCorin 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 TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.
Quantity2 units
Recall ReasonThe 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 Classification20211006
Device Code InfoThe 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 Date20210930
Recall Initiation Date20210728
Recalling FirmCorin Ltd
Initial Notification E-Mail
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