BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-2611-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2611-2021
    Event ID
    88589
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Corin Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 6, 2021
    Initiation Date
    July 28, 2021
    Classification Date
    September 30, 2021
    Termination Date
    June 12, 2024
    Address
    Unit 1-57-8, Corinium Centre, Cirencester, N/A, N/A, United Kingdom

    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.

    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.

    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.

    Distribution

    US Nationwide distribution in the states of AZ, CA, FL, IL, OK, PA, TX, UT, and WI.

    Quantity

    2 units