BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

    Recall: Z-0085-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0085-2019
    Event ID
    80845
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthosensor, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 17, 2018
    Initiation Date
    July 12, 2018
    Classification Date
    October 5, 2018
    Termination Date
    June 27, 2019
    Address
    1855 Griffin Rd Ste A310, Dania, FL, 33004-2401, United States

    Description

    OrthoSensor VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, REF ZBH-PSNCRCD39-R.

    Reason

    Some sensors were reported to have fluid inside the posterior lateral corner post-surgery.

    Code Info

    Lot numbers 20598 and 20607, UDI 00816818021423.

    Distribution

    Distribution was made CA, FL, IL, IN, MI, NY, and NC. Foreign distribution was made to Australia. There was no government/military distribution.

    Quantity

    36 devices