BEUDAMED
    FDA Enforcement Class II Terminated

    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

    Recall: Z-0702-2019 · Reported January 16, 2019

    Enforcement

    Recall Number
    Z-0702-2019
    Event ID
    81756
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardinal Health Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 16, 2019
    Initiation Date
    November 16, 2018
    Classification Date
    January 9, 2019
    Termination Date
    November 4, 2019
    Address
    7000 Cardinal Pl, Dublin, OH, 43017-1091, United States

    Description

    Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.

    Reason

    The double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.

    Code Info

    Product code: SOP22TJCLK Lot numbers # 104405, 122793, and 987948

    Distribution

    US state of Florida

    Quantity

    182 packs